Application 214790

Type: ANDA
Sponsor: ASCENT PHARMS INC

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 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214790-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03
A214790-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03
A214790-003	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03
A214790-004	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL		RS	2026-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214790-001	AB
A214790-002	AB
A214790-003	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 3 · 103 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214790-004	SERTRALINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL		RS	2026-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214790-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB		2021-05-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214790-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2021-05-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214790-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB		2021-05-03	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214790-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214790-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214790-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214790-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214790-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214790-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214790-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214790-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214790-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214790-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214790-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214790-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214790-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214790-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214790-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214790-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214790-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214790-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214790-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214790-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214790-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214790-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214790-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214790-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214790-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214790-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214790-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214790-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214790-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214790-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214790-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214790-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214790-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214790-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214790-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214790-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214790-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214790-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214790-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214790-001	AB	1	`1e350fbaab3a…`

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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	48702ef4-21cd-754e-e063-6394a90af24e	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	2bb3a2d1-76c4-42e6-8553-aa95f263175b	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	c0cc1b03-ba35-4a2c-be95-2d9b7f4c3499	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	50b54bfa-0b90-44f1-8f73-4f7f552449c4	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	45af84f5-c284-4e82-ad3c-e9b7ab2b8114	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	de1f85ac-df1b-4b7b-8e18-48ebdc8b9279	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790 ndc (product): 31722-147 ndc (product): 31722-145 ndc (product): 31722-146
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	5b73a90e-b883-419b-b30f-a379eed764d9	2023-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790 ndc (product): 72865-206 ndc (product): 72865-205 ndc (product): 72865-207
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Ascent Pharmaceuticals, Inc.	056191ca-999a-4c9b-93b9-64db44b8e628	2021-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214790 application number: ANDA214790 ndc (product): 43602-979 ndc (product): 43602-980 ndc (product): 43602-981

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-145	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-145	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-145	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-146	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-146	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-146	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-147	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-147	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-147	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
43602-462	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Ascent Pharmaceuticals, Inc	ANDA	Current
43602-463	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Ascent Pharmaceuticals, Inc	ANDA	Current
43602-464	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Ascent Pharmaceuticals, Inc	ANDA	Current
43602-979	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-980	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Ascent Pharmaceuticals, Inc.	ANDA	Current
43602-981	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Ascent Pharmaceuticals, Inc.	ANDA	Current
72865-205	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-205	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-206	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-206	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-207	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-207	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	XLCare Pharmaceuticals, Inc.	ANDA	Current