Application 077670

Type: ANDA
Sponsor: LUPIN

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	TE codes	Approval date
A077670-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06
A077670-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06
A077670-003	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077670-001	AB
A077670-002	AB
A077670-003	AB

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A077670-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077670-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077670-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077670-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077670-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077670-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077670-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077670-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077670-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077670-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077670-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077670-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077670-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077670-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077670-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077670-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077670-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077670-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077670-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077670-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077670-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077670-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077670-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077670-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077670-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077670-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077670-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077670-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077670-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077670-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077670-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077670-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077670-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077670-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077670-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077670-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077670-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077670-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077670-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077670-001	AB	1	`79d66fd596c7…`

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 2 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	a06f2cf6-ccef-47bf-aba8-a42bada46d8b	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	473d6055-b811-4ffb-9398-88f50a152196	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	42120ff8-b353-4632-9ea9-54de9a698724	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	AvPAK	40be43b2-649b-0928-e063-6394a90a3b48	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	NuCare Pharmaceuticals,Inc.	0a1f7d44-c339-a4dd-e063-6294a90ac0de	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	Quality Care Products, LLC	6ed2b9b7-e4af-4e28-a7d5-4ccb514af217	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	A-S Medication Solutions	e93391c9-db88-4fa5-b1d5-f6c6de78b31c	2024-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	A-S Medication Solutions	f5bf9595-d9f9-40b1-9b3b-da277fd5ab7f	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	A-S Medication Solutions	b2533b60-cc54-4905-a4ee-ea08a160f8c6	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	A-S Medication Solutions	cbc2bd3b-03fc-47b9-91d1-8989ec90c7e6	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	NuCare Pharmaceuticals,Inc.	1ac8a624-2292-b7b8-e063-6394a90a165b	2024-06-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	Proficient Rx LP	35dea1a2-ec26-4e52-8f09-ee4678e77946	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670

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 2 of 2 · 119 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-0201	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-0201	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-0240	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-0240	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-0240	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-0378	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-0378	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-0378	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-0378	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-0938	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-0938	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1040	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1040	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1040	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1040	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1040	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1040	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1290	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1290	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1461	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1461	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1461	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1461	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1617	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1617	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1617	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1617	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1617	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1617	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-1617	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-2512	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-2512	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-2512	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70518-2512	Sertraline	Sertraline	REMEDYREPACK INC.	ANDA	Current
70934-958	Sertraline	Sertraline	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0404	Sertraline	Sertraline	Bryant Ranch Prepack	ANDA	Current
71335-0404	Sertraline	Sertraline	Bryant Ranch Prepack	ANDA	Current
71335-0404	Sertraline	Sertraline	Bryant Ranch Prepack	ANDA	Current
71335-0404	Sertraline	Sertraline	Bryant Ranch Prepack	ANDA	Current