FDA Orange Book · active-ingredient family
Sertraline hydrochloride
Sertraline hydrochloride: 3 brands, 36 generics; first approved Dec 30, 1991; generic available.
Generic available2 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 36 ANDA applications approved.
Latest exclusivity ends
Brands (NDA)
3
Generics (ANDA)
36
Listed patents
0
Presentations
107
Brand (NDA) products
Originator applications
- SERTRALINE HYDROCHLORIDERLDRSALMATICANDA 21513320212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Rx AB EQ 200MG BASE CAPSULE ORAL Rx AB - VIATRISNDA 0209901999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/ML CONCENTRATE ORAL Rx AA - ZOLOFTRLDVIATRISNDA 01983919965 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB EQ 150MG BASE TABLET ORAL Discontinued — EQ 200MG BASE TABLET ORAL Discontinued — EQ 25MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (36)
Abbreviated applications
- SERTRALINE HYDROCHLORIDEZYDUS LIFESCIENCESANDA 22027520262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Rx AB EQ 200MG BASE CAPSULE ORAL Rx AB - SERTRALINE HYDROCHLORIDEAMNEALANDA 21965520262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Rx AB EQ 200MG BASE CAPSULE ORAL Rx AB - SERTRALINE HYDROCHLORIDEAPPCOANDA 21871220262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Rx AB EQ 200MG BASE CAPSULE ORAL Rx AB - SERTRALINE HYDROCHLORIDENOVITIUM PHARMAANDA 21971420262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Rx AB EQ 200MG BASE CAPSULE ORAL Rx AB - SERTRALINE HYDROCHLORIDEUMEDICAANDA 21834220262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Rx AB EQ 200MG BASE CAPSULE ORAL Rx AB - SERTRALINE HYDROCHLORIDEZENARAANDA 21885320252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Rx AB EQ 200MG BASE CAPSULE ORAL Rx AB - SERTRALINE HYDROCHLORIDEASCENT PHARMS INCANDA 21479020214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB EQ 75MG BASE TABLET ORAL Rx — - SERTRALINE HYDROCHLORIDEACCORD HLTHCAREANDA 20282520143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SERTRALINE HYDROCHLORIDEOXFORD PHARMSANDA 07817520103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SERTRALINE HYDROCHLORIDEHIKMA PHARMSANDA 07786420093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SERTRALINE HYDROCHLORIDEREYOUNGANDA 07867720093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SERTRALINE HYDROCHLORIDEAUROBINDO PHARMAANDA 0788612008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/ML CONCENTRATE ORAL Rx AA - SERTRALINE HYDROCHLORIDEQUAGENANDA 07862620083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SERTRALINE HYDROCHLORIDEGRANULESANDA 07840320083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SERTRALINE HYDROCHLORIDESCIEGEN PHARMSANDA 07644220073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SERTRALINE HYDROCHLORIDEMYLAN PHARMS INCANDA 07654020073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SERTRALINE HYDROCHLORIDEAPPCOANDA 07771320073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SERTRALINE HYDROCHLORIDEAUROBINDO PHARMAANDA 07720620073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SERTRALINE HYDROCHLORIDECHARTWELL MOLECULARANDA 07716220073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SERTRALINE HYDROCHLORIDEHERITAGE PHARMA AVETANDA 07729920073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SERTRALINE HYDROCHLORIDEHERITAGE PHARMA AVETANDA 07734520073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SERTRALINE HYDROCHLORIDEHERITAGE PHARMA AVETANDA 07766320073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SERTRALINE HYDROCHLORIDEINVAGEN PHARMSANDA 07739720073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SERTRALINE HYDROCHLORIDELUPINANDA 07767020073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SERTRALINE HYDROCHLORIDEPHARMACOANDA 07688220073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SERTRALINE HYDROCHLORIDEPHARMOBEDIENTANDA 07667120073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SERTRALINE HYDROCHLORIDESTRIDES PHARMAANDA 07688120073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SERTRALINE HYDROCHLORIDESUN PHARM INDS (IN)ANDA 07810820073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SERTRALINE HYDROCHLORIDESUN PHARM INDS LTDANDA 07797720075 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — EQ 150MG BASE TABLET ORAL Discontinued — EQ 200MG BASE TABLET ORAL Discontinued — - SERTRALINE HYDROCHLORIDETORRENT PHARMSANDA 07776520073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SERTRALINE HYDROCHLORIDETP ANDA HOLDINGSANDA 07781820073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SERTRALINE HYDROCHLORIDEZYDUSANDA 07710620073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SERTRALINE HYDROCHLORIDERANBAXY LABS LTDANDA 0780532007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/ML CONCENTRATE ORAL Discontinued — - SERTRALINE HYDROCHLORIDEHERITAGEANDA 07646520063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SERTRALINE HYDROCHLORIDESTRIDES PHARMAANDA 0769342006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/ML CONCENTRATE ORAL Rx AA - SERTRALINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 07571920063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — EQ 25MG BASE TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- CGTFDA marketing exclusivity
8 mo ago
- CGTFDA marketing exclusivity
8 mo ago
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
35 yr 3 mo ago
Most recent approval
1 mo ago
Approvals span 1991–2026 across 39 FDA applications.
Brand (NDA) 38%
Generic (ANDA) 3692%
Sertraline 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
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- 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.
