Home Applications 076442 Application 076442
Type ANDA
Sponsor SCIEGEN PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE No No 002 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE No No 003 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076442-001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 A076442-002 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 A076442-003 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 102 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 23824 ORIG 2007-05-08