Home Applications 076934 Application 076934
Type ANDA
Sponsor ACI HEALTHCARE LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE CONCENTRATE;ORAL EQ 20MG BASE/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076934-001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076934-001 AA
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 2 · 42 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 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL 2006-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL 2006-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL 2006-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL 2006-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL 2006-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 e64feba35796…
Observed Orange Book normalized TE history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10135-694 Sertraline Hydrochloride Sertraline Hydrochloride Marlex Pharmaceuticals Inc ANDA Current 63629-8774 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE Bryant Ranch Prepack ANDA Current 63629-8774 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE Bryant Ranch Prepack ANDA Current 63629-8774 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE Bryant Ranch Prepack ANDA Current 63629-8774 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE Bryant Ranch Prepack ANDA Current 71093-143 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE ACI Healthcare USA, Inc. ANDA Current 71093-143 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE ACI Healthcare USA, Inc. ANDA Current 71093-143 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE ACI Healthcare USA, Inc. ANDA Current 71093-143 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE ACI Healthcare USA, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 23843 ORIG 2006-07-05 31176 ORIG 2006-07-03