Application 077977

Type: ANDA
Sponsor: SUN PHARM INDS LTD

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
004	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	TABLET;ORAL	EQ 150MG BASE	No	No
005	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	TABLET;ORAL	EQ 200MG 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077977-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06
A077977-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06
A077977-003	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06
A077977-004	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06
A077977-005	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 200MG 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 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077977-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2007-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077977-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2007-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077977-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2007-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077977-004	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077977-005	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	2007-02-06	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077977-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077977-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077977-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077977-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077977-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077977-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077977-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077977-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077977-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077977-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077977-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077977-003	AB	1	`ea99ee380514…`

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 5 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	Aphena Pharma Solutions - Tennessee, LLC	680890b1-bc45-4f50-9aaf-e730ab515b85	2025-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Asclemed USA, Inc.	e25a13c3-a173-4cc3-99d3-0be43abbc498	2025-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Coupler LLC	2ce05049-030f-3e8b-e063-6394a90a4885	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	DIRECT RX	ab962a5a-fff6-2cf9-e053-2995a90ace0f	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	c4bad433-623b-402c-b454-d39f19a23627	2025-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	0e5a7b02-3972-47f0-9f49-e958d792beac	2025-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ae3be25b-2bde-4142-ad56-920a96ac8f39	2025-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	ec1b68d3-ff55-d0a2-e053-2a95a90a2e0b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8c45a99-18ed-0e1f-e053-6394a90a2d52	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Quality Care Products LLC	25aef6c1-9964-44a1-a905-c37e5c28a3c0	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	American Health Packaging	4e09f580-d612-416c-a4a4-79a4411845b2	2024-11-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	f705f743-40e9-42bf-88f5-6dd7e5d5ba94	2024-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	4f6f2412-8085-45bf-be4f-63e44490a34e	2024-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	9f1d5689-3bf1-431c-9ea2-9e37217ecf40	2024-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	4191b929-5bdb-4388-9e4d-fffce55bc363	2024-10-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	1a58062b-e635-431a-908d-2651c6a4a21c	2024-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	de1f85ac-df1b-4b7b-8e18-48ebdc8b9279	2024-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	fa260c6c-9f6a-46a3-91ce-5665739d87e7	2024-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NorthStar Rx LLC	7f144b68-ae90-483c-b030-f6824662a734	2024-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	c6897cf2-1349-400d-ab22-1e88f097b693	2024-08-08	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63304-164	Sertraline Hydrochloride	Sertraline Hydrochloride	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-165	Sertraline Hydrochloride	Sertraline Hydrochloride	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-166	Sertraline Hydrochloride	Sertraline Hydrochloride	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-167	Sertraline Hydrochloride	Sertraline Hydrochloride	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-168	Sertraline Hydrochloride	Sertraline Hydrochloride	Ranbaxy Pharmaceuticals Inc.	ANDA	Current