FDA Orange Book · active-ingredient family
Amitriptyline hydrochloride
Amitriptyline hydrochloride: 2 brands, 130 generics; first approved Jan 04, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 130 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
130
Listed patents
0
Presentations
218
Brand (NDA) products
Originator applications
- ELAVILRLDASTRAZENECANDA 012703—6 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — - ASTRAZENECANDA 012704—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (130)
Abbreviated applications
- AMITRIPTYLINE HYDROCHLORIDEUNIQUE PHARMANDA 21838920256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - AMITRIPTYLINE HYDROCHLORIDERISINGANDA 21741120236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - AMITRIPTYLINE HYDROCHLORIDERUBICON RESEARCHANDA 21537620236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - AMITRIPTYLINE HYDROCHLORIDEBRECKENRIDGEANDA 21624320226 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEAIPING PHARM INCANDA 21265420216 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - AMITRIPTYLINE HYDROCHLORIDEUNICHEMANDA 21454820216 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - AMITRIPTYLINE HYDROCHLORIDEMANKIND PHARMAANDA 21399920216 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - AMITRIPTYLINE HYDROCHLORIDEZYDUS PHARMSANDA 21008620176 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - AMITRIPTYLINE HYDROCHLORIDEACCORD HLTHCAREANDA 20244620146 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - AMITRIPTYLINE HYDROCHLORIDESUN PHARM INDS INCANDA 04081620086 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPH HEALTHANDA 04021819976 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDESUN PHARM INDS INCANDA 08939919876 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - AMITRIPTYLINE HYDROCHLORIDEMUTUAL PHARMANDA 0894231987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEAM THERAPANDA 0886721984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEAM THERAPANDA 0886731984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEAM THERAPANDA 0886741984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEAM THERAPANDA 0886751984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDESUPERPHARMANDA 0888531984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDESUPERPHARMANDA 0888541984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDESUPERPHARMANDA 0888551984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDESUPERPHARMANDA 0888561984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDESUPERPHARMANDA 0888571984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPLIVAANDA 0888831984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPLIVAANDA 0888841984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPLIVAANDA 0888851984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPLIVAANDA 0888861984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPLIVAANDA 0888871984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPLIVAANDA 0888881984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 0886971984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 0886981984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 0886991984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 0887001984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 0887011984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 0887021984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDECOPLEY PHARMANDA 0884211984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDECOPLEY PHARMANDA 0884221984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDECOPLEY PHARMANDA 0884231984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDECOPLEY PHARMANDA 0884241984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDECOPLEY PHARMANDA 0884251984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDECOPLEY PHARMANDA 0884261984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 0886201984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 0886211984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 0886221984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 0886331984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 0886341984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 0886351984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 0880751983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 0880771983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 0880781983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 0880791983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 0880841983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 0880851983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 0881051983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 0881061983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 0881071983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEHALSEYANDA 0859261983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEHALSEYANDA 0859271983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 0880761983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEMUTUAL PHARMANDA 0857421982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 0873671982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 0873681982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEHALSEYANDA 0875571982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWEST WARDANDA 0876471982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEUSL PHARMAANDA 0877751982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEVANGARDANDA 0876161982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEVANGARDANDA 0876391982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEVANGARDANDA 0876171982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEVANGARDANDA 0876321982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 0873661982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 0871811982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 0873691982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 0873701982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — - ENDEPRLDROCHEANDA 085749—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML CONCENTRATE ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 085594—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - BRISTOL MYERS SQUIBBANDA 086454—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - WARNER CHILCOTTANDA 083939—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - WARNER CHILCOTTANDA 083937—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - WARNER CHILCOTTANDA 083938—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - WARNER CHILCOTTANDA 084957—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - WARNER CHILCOTTANDA 085093—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - WARNER CHILCOTTANDA 086295—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEANI PHARMSANDA 085031—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEAUROBINDO PHARMA USAANDA 086009—6 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - AMITRIPTYLINE HYDROCHLORIDEHALSEYANDA 085923—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEHALSEYANDA 085922—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEHALSEYANDA 085925—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 086744—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 086746—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 086743—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 086745—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 086747—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEMUTUAL PHARMANDA 085744—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEMUTUAL PHARMANDA 085627—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEMUTUAL PHARMANDA 085745—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEMUTUAL PHARMANDA 085743—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086002—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086144—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 085944—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086145—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 085945—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086143—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086004—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086147—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086003—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086146—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086090—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086148—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDERLDSANDOZANDA 085968—6 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB - AMITRIPTYLINE HYDROCHLORIDETEVAANDA 086610—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDETEVAANDA 086859—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDETEVAANDA 086857—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDETEVAANDA 086860—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDETEVAANDA 085836—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDETEVAANDA 086854—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDETEVAANDA 086853—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEUCB INCANDA 085864—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEUCB INCANDA 085935—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEUCB INCANDA 085936—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEUCB INCANDA 086337—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEUCB INCANDA 086336—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEUCB INCANDA 086335—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 085816—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 085817—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 085815—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 085819—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 085820—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 085821—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — - AMITRIPTYLINE HYDROCHLORIDEWEST WARDANDA 087278—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — - ROCHEANDA 083639—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - ROCHEANDA 085303—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
45 yr 2 mo ago
Most recent approval
1 yr 1 mo ago
Approvals span 1982–2025 across 132 FDA applications.
Brand (NDA) 22%
Generic (ANDA) 13098%
Amitriptyline hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
