Application 077345

Type: ANDA
Sponsor: HERITAGE PHARMA

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 44.

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	Approval date
A077345-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06
A077345-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06
A077345-003	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06

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 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A077345-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077345-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077345-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077345-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077345-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077345-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077345-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077345-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077345-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077345-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077345-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077345-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077345-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077345-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077345-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077345-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077345-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077345-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077345-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077345-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077345-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077345-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077345-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077345-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077345-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077345-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077345-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077345-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077345-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077345-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077345-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077345-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077345-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077345-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077345-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077345-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077345-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077345-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077345-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077345-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`3a93d1ddd44b…`

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 7 · 134 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	7d598f1a-6c76-458a-a155-7a6a0743a2d3	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	455c8416-c878-4283-a42f-4df896870a4e	2026-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	b559c20d-70be-41e7-acfb-262ffc3ea878	2026-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5921f77f-01a2-40b9-ad77-2258865c997d	2026-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	4da914d0-629e-4766-b57f-6119fa8283cf	2026-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	677c90cd-6527-40cb-a564-571796513fcb	2026-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	1afd0016-d0ee-4e25-a1a4-b66f228e2f9c	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Cardinal Health 107, LLC	7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee6	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline HCl	SERTRALINE HYDROCHLORIDE	Umedica Laboratories USA Inc.	a6d0f35c-f4f4-456d-b8d9-d56297261ad6	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	adfcc867-1b6e-4698-94b6-2b4190c4ba3d	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	52c88667-c67e-4d42-b319-afb354713b1e	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	9dacf5b7-1a23-4767-a074-11f26623e48b	2026-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	91e24d17-ff0a-449c-9472-b9df74c98456	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	a2f333af-d37b-4705-ab7a-d363e3186e6e	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	9d49e2cb-a852-403d-b92b-e7d3fa88032c	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	f6346a11-88b9-4425-b08d-a22f19c4ceb4	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	7b5c29ff-25c8-4b68-844d-b8e95be7d09b	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Coupler LLC	56442b06-c135-a035-e063-6394a90a171b	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	561a8a20-be26-c4f8-e063-6394a90af072	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	561e7498-a606-366d-e063-6394a90a1c6a	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.