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 4 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	Aurobindo Pharma Limited	b497dfeb-a48c-4f2a-b309-b56f3a26a19b	2025-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	b400fed8-f425-47ff-ab42-915cb6e7f152	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	8f5a71b2-2821-46a0-ac65-28d9b2db73ec	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	0de9e3e3-912a-428b-89d2-70811a56cdc5	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	1b069fd8-26b9-459e-abfb-de28c012ddcb	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	a06f2cf6-ccef-47bf-aba8-a42bada46d8b	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	473d6055-b811-4ffb-9398-88f50a152196	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	42120ff8-b353-4632-9ea9-54de9a698724	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	2bb3a2d1-76c4-42e6-8553-aa95f263175b	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	c0cc1b03-ba35-4a2c-be95-2d9b7f4c3499	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	50b54bfa-0b90-44f1-8f73-4f7f552449c4	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	45af84f5-c284-4e82-ad3c-e9b7ab2b8114	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SERTRALINE HYDROCHLORIDE generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3ca30f3f-545e-46c5-b56a-73ec48e9647f	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	AvPAK	40be43b2-649b-0928-e063-6394a90a3b48	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	91b4c802-9c6b-49bb-b5a7-661e1917ef34	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Alvogen, Inc.	e0e1f35e-114d-bb39-34f1-70208b94ac9e	2025-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: sertraline hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	50d0aef5-ecc7-49b0-964a-53f87058d22a	2025-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Cipla USA Inc.	3a3efb5f-b24a-438d-9253-371ff3b5417d	2025-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	23f1c8c5-032c-4ea9-beb0-ca3a614ba4b6	2025-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sertraline Hydrochloride generic name: SERTRALINE HYDROCHLORIDE
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	30b94d67-0000-a045-e063-6394a90ade32	2025-03-19	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