Assyro AI

FDA Orange Book · active-ingredient family

Amitriptyline hydrochloride

Amitriptyline hydrochloride is approved as 2 brand and 130 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ELAVIL · NDA 012703

2

Brand (NDA)

130

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · concentrate, injectable, tablet

ProductApplicantApplicationTEApproved
ELAVILRLD×6ASTRAZENECANDA 012703—Approved Prior to Jan 1, 1982
ELAVILASTRAZENECANDA 012704—Approved Prior to Jan 1, 1982

Generic (ANDA) products (130)

ProductApplicantApplicationTEApproved
AMITRIPTYLINE HYDROCHLORIDE×6UNIQUE PHARMANDA 218389ABJun 23, 2025
AMITRIPTYLINE HYDROCHLORIDE×6RISINGANDA 217411ABMay 19, 2023
AMITRIPTYLINE HYDROCHLORIDE×6RUBICON RESEARCHANDA 215376ABMay 01, 2023
AMITRIPTYLINE HYDROCHLORIDE×6BRECKENRIDGEANDA 216243—Jun 06, 2022
AMITRIPTYLINE HYDROCHLORIDE×6AIPING PHARM INCANDA 212654ABSep 29, 2021
AMITRIPTYLINE HYDROCHLORIDE×6UNICHEMANDA 214548ABMay 19, 2021
AMITRIPTYLINE HYDROCHLORIDE×6MANKIND PHARMAANDA 213999ABFeb 19, 2021
AMITRIPTYLINE HYDROCHLORIDE×6ZYDUS PHARMSANDA 210086ABOct 06, 2017
AMITRIPTYLINE HYDROCHLORIDE×6ACCORD HLTHCAREANDA 202446ABJun 04, 2014
AMITRIPTYLINE HYDROCHLORIDE×6SUN PHARM INDS INCANDA 040816—Jun 27, 2008
AMITRIPTYLINE HYDROCHLORIDE×6PH HEALTHANDA 040218—Sep 11, 1997
AMITRIPTYLINE HYDROCHLORIDE×6SUN PHARM INDS INCANDA 089399ABJul 14, 1987
AMITRIPTYLINE HYDROCHLORIDEMUTUAL PHARMANDA 089423—Feb 17, 1987
AMITRIPTYLINE HYDROCHLORIDEAM THERAPANDA 088672—Nov 20, 1984
AMITRIPTYLINE HYDROCHLORIDEAM THERAPANDA 088673—Nov 20, 1984
AMITRIPTYLINE HYDROCHLORIDEAM THERAPANDA 088674—Nov 20, 1984
AMITRIPTYLINE HYDROCHLORIDEAM THERAPANDA 088675—Nov 20, 1984
AMITRIPTYLINE HYDROCHLORIDESUPERPHARMANDA 088853—Nov 13, 1984
AMITRIPTYLINE HYDROCHLORIDESUPERPHARMANDA 088854—Nov 13, 1984
AMITRIPTYLINE HYDROCHLORIDESUPERPHARMANDA 088855—Nov 13, 1984
AMITRIPTYLINE HYDROCHLORIDESUPERPHARMANDA 088856—Nov 13, 1984
AMITRIPTYLINE HYDROCHLORIDESUPERPHARMANDA 088857—Nov 13, 1984
AMITRIPTYLINE HYDROCHLORIDEPLIVAANDA 088883—Sep 26, 1984
AMITRIPTYLINE HYDROCHLORIDEPLIVAANDA 088884—Sep 26, 1984
AMITRIPTYLINE HYDROCHLORIDEPLIVAANDA 088885—Sep 26, 1984
AMITRIPTYLINE HYDROCHLORIDEPLIVAANDA 088886—Sep 26, 1984
AMITRIPTYLINE HYDROCHLORIDEPLIVAANDA 088887—Sep 26, 1984
AMITRIPTYLINE HYDROCHLORIDEPLIVAANDA 088888—Sep 26, 1984
AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 088697—Sep 25, 1984
AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 088698—Sep 25, 1984
AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 088699—Sep 25, 1984
AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 088700—Sep 25, 1984
AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 088701—Sep 25, 1984
AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 088702—Sep 25, 1984
AMITRIPTYLINE HYDROCHLORIDECOPLEY PHARMANDA 088421—Apr 30, 1984
AMITRIPTYLINE HYDROCHLORIDECOPLEY PHARMANDA 088422—Apr 30, 1984
AMITRIPTYLINE HYDROCHLORIDECOPLEY PHARMANDA 088423—Apr 30, 1984
AMITRIPTYLINE HYDROCHLORIDECOPLEY PHARMANDA 088424—Apr 30, 1984
AMITRIPTYLINE HYDROCHLORIDECOPLEY PHARMANDA 088425—Apr 30, 1984
AMITRIPTYLINE HYDROCHLORIDECOPLEY PHARMANDA 088426—Apr 30, 1984
AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 088620—Mar 02, 1984
AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 088621—Mar 02, 1984
AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 088622—Mar 02, 1984
AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 088633—Mar 02, 1984
AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 088634—Mar 02, 1984
AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 088635—Mar 02, 1984
AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 088075—Sep 16, 1983
AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 088077—Sep 16, 1983
AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 088078—Sep 16, 1983
AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 088079—Sep 16, 1983
AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 088084—Jul 18, 1983
AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 088085—Jul 18, 1983
AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 088105—Jul 18, 1983
AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 088106—Jul 18, 1983
AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 088107—Jul 18, 1983
AMITRIPTYLINE HYDROCHLORIDEHALSEYANDA 085926—May 20, 1983
AMITRIPTYLINE HYDROCHLORIDEHALSEYANDA 085927—May 20, 1983
AMITRIPTYLINE HYDROCHLORIDEPUREPAC PHARMANDA 088076—May 20, 1983
AMITRIPTYLINE HYDROCHLORIDEMUTUAL PHARMANDA 085742—May 11, 1982
AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 087367—May 03, 1982
AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 087368—May 03, 1982
AMITRIPTYLINE HYDROCHLORIDEHALSEYANDA 087557—Mar 05, 1982
AMITRIPTYLINE HYDROCHLORIDEWEST WARDANDA 087647—Mar 05, 1982
AMITRIPTYLINE HYDROCHLORIDEUSL PHARMAANDA 087775—Feb 10, 1982
AMITRIPTYLINE HYDROCHLORIDEVANGARDANDA 087616—Feb 08, 1982
AMITRIPTYLINE HYDROCHLORIDEVANGARDANDA 087639—Feb 08, 1982
AMITRIPTYLINE HYDROCHLORIDEVANGARDANDA 087617—Feb 05, 1982
AMITRIPTYLINE HYDROCHLORIDEVANGARDANDA 087632—Feb 01, 1982
AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 087366—Jan 04, 1982
AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 087181—Jan 04, 1982
AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 087369—Jan 04, 1982
AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 087370—Jan 04, 1982
ENDEPRLDROCHEANDA 085749—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 085594—Approved Prior to Jan 1, 1982
AMITID×5BRISTOL MYERS SQUIBBANDA 086454—Approved Prior to Jan 1, 1982
AMITRILWARNER CHILCOTTANDA 083939—Approved Prior to Jan 1, 1982
AMITRILWARNER CHILCOTTANDA 083937—Approved Prior to Jan 1, 1982
AMITRILWARNER CHILCOTTANDA 083938—Approved Prior to Jan 1, 1982
AMITRILWARNER CHILCOTTANDA 084957—Approved Prior to Jan 1, 1982
AMITRILWARNER CHILCOTTANDA 085093—Approved Prior to Jan 1, 1982
AMITRILWARNER CHILCOTTANDA 086295—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDE×4ANI PHARMSANDA 085031—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDE×6AUROBINDO PHARMA USAANDA 086009ABApproved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEHALSEYANDA 085923—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEHALSEYANDA 085922—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEHALSEYANDA 085925—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 086744—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 086746—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 086743—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 086745—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDELEDERLEANDA 086747—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEMUTUAL PHARMANDA 085744—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEMUTUAL PHARMANDA 085627—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEMUTUAL PHARMANDA 085745—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEMUTUAL PHARMANDA 085743—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086002—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086144—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 085944—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086145—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 085945—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086143—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086004—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086147—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086003—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086146—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086090—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEROXANEANDA 086148—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDERLD×6SANDOZANDA 085968ABApproved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDETEVAANDA 086610—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDETEVAANDA 086859—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDETEVAANDA 086857—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDETEVAANDA 086860—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDETEVAANDA 085836—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDETEVAANDA 086854—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDETEVAANDA 086853—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEUCB INCANDA 085864—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEUCB INCANDA 085935—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEUCB INCANDA 085936—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEUCB INCANDA 086337—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEUCB INCANDA 086336—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEUCB INCANDA 086335—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 085816—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 085817—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 085815—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 085819—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 085820—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 085821—Approved Prior to Jan 1, 1982
AMITRIPTYLINE HYDROCHLORIDEWEST WARDANDA 087278—Approved Prior to Jan 1, 1982
ENDEP×5ROCHEANDA 083639—Approved Prior to Jan 1, 1982
ENDEPROCHEANDA 085303—Approved Prior to Jan 1, 1982

Listed patents

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.

Amitriptyline hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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