Application 078108

Type: ANDA
Sponsor: SUN PHARM INDS (IN)

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 43.

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
A078108-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06
A078108-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06
A078108-003	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 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078108-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078108-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078108-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078108-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078108-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078108-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078108-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078108-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078108-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078108-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078108-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078108-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078108-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078108-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078108-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078108-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078108-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078108-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078108-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078108-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078108-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078108-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078108-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078108-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078108-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078108-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078108-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078108-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078108-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078108-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078108-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078108-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078108-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078108-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078108-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078108-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078108-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078108-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078108-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078108-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`301d65b070ca…`

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 6 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	Bryant Ranch Prepack	2f81b0c4-9ad9-4dda-8950-70321a8769e4	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	dfc9fee6-c032-4994-9f14-5beaf39bb5d5	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	af2c75a3-131e-4bde-83fd-310fd2c01161	2024-06-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8e105aeb-6e17-a025-e053-2995a90aba77	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8e98ee4c-24df-88ce-e053-2a95a90a6713	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7cadc747-5606-8efe-e053-2991aa0a1d8f	2024-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6dd71a5b-1923-54fb-e053-2991aa0a619e	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	71224928-685a-355c-e053-2995a90a0a5b	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	5c6c817e-a555-4f55-837d-94458787fcb6	2024-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	22c4b114-5f70-4c64-aa7f-b4169729b847	2024-04-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	9bcef7ef-4e2f-4ab9-9c0f-f4956bfdd71b	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	82a44e20-d0ee-4ed7-9234-24ef4496ac1d	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Aurobindo Pharma Limited	01800452-c353-4235-a66a-214048752e74	2024-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Aurobindo Pharma Limited	39a85db1-9e59-4ab0-9e18-36757f019faa	2024-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NorthStar Rx LLC	9bc362d4-489c-4e7f-915a-3076ff8d132a	2024-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	75a43476-25e0-44c3-bbab-2160041032d1	2023-12-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	626a9271-a268-4194-935d-779377f902f5	2023-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	ScieGen Pharmaceuticals Inc	10b9cae4-b452-4abb-866a-9f9d2568f212	2023-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	286b429d-62b9-4ca8-a243-de3f619315bf	2023-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
sertraline HCl	SERTRALINE HYDROCHLORIDE	Almatica Pharma LLC	8c8bcba9-eaeb-aa44-f9ea-b580de55a439	2023-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SERTRALINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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