Application 019839

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOLOFT	SERTRALINE HYDROCHLORIDE	TABLET;ORAL	EQ 50MG BASE	Yes	No
002	ZOLOFT	SERTRALINE HYDROCHLORIDE	TABLET;ORAL	EQ 100MG BASE	Yes	Yes
003	ZOLOFT	SERTRALINE HYDROCHLORIDE	TABLET;ORAL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	ZOLOFT	SERTRALINE HYDROCHLORIDE	TABLET;ORAL	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	ZOLOFT	SERTRALINE HYDROCHLORIDE	TABLET;ORAL	EQ 25MG BASE	Yes	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	TE codes	RLD / RS	Approval date
N019839-001	ZOLOFT	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1991-12-30
N019839-002	ZOLOFT	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1991-12-30
N019839-003	ZOLOFT	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30
N019839-004	ZOLOFT	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30
N019839-005	ZOLOFT	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1996-03-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019839-001	AB
N019839-002	AB
N019839-005	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 2 of 6 · 220 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
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019839-001	ZOLOFT	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1991-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019839-002	ZOLOFT	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1991-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019839-003	ZOLOFT	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019839-004	ZOLOFT	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019839-005	ZOLOFT	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1996-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019839-001	ZOLOFT	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1991-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019839-002	ZOLOFT	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1991-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019839-003	ZOLOFT	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019839-004	ZOLOFT	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019839-005	ZOLOFT	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1996-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019839-001	ZOLOFT	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1991-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019839-002	ZOLOFT	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1991-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019839-003	ZOLOFT	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019839-004	ZOLOFT	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019839-005	ZOLOFT	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1996-03-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019839-001	ZOLOFT	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1991-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019839-002	ZOLOFT	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1991-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019839-003	ZOLOFT	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019839-004	ZOLOFT	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019839-005	ZOLOFT	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1996-03-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019839-001	ZOLOFT	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1991-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019839-002	ZOLOFT	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1991-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019839-003	ZOLOFT	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019839-004	ZOLOFT	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019839-005	ZOLOFT	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1996-03-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019839-001	ZOLOFT	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1991-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019839-002	ZOLOFT	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1991-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019839-003	ZOLOFT	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019839-004	ZOLOFT	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019839-005	ZOLOFT	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1996-03-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019839-001	ZOLOFT	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1991-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019839-002	ZOLOFT	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1991-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019839-003	ZOLOFT	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019839-004	ZOLOFT	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019839-005	ZOLOFT	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1996-03-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019839-001	ZOLOFT	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1991-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019839-002	ZOLOFT	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1991-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019839-003	ZOLOFT	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019839-004	ZOLOFT	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1991-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019839-005	ZOLOFT	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1996-03-06	`1e350fbaab3a…`

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	N019839-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019839-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019839-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019839-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019839-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019839-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019839-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019839-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019839-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019839-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019839-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019839-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019839-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019839-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019839-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019839-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019839-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019839-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019839-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019839-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019839-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019839-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019839-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019839-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019839-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019839-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019839-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019839-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019839-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019839-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019839-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019839-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019839-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019839-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019839-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019839-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019839-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019839-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019839-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019839-001	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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zoloft	SERTRALINE HYDROCHLORIDE	Viatris Specialty LLC	fda754f6-d0f3-4dce-a17a-927d64f912f7	2023-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019839 application number: NDA019839

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 · 74 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0049-4900	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4900	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4900	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4900	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4900	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4900	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4900	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4900	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4900	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4900	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4910	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4910	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4910	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4910	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4910	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4910	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4910	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4910	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4910	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4910	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4960	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4960	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4960	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4960	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4960	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4960	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4960	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4960	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4960	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
0049-4960	Zoloft	sertraline hydrochloride	Roerig	NDA	Current
43063-411	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
43063-411	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
53808-0582	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	State of Florida DOH Central Pharmacy	NDA	Current
55154-0527	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Cardinal Health	NDA	Current
55154-0532	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Cardinal Health	NDA	Current
55289-381	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	PD-Rx Pharmaceuticals, In	NDA AUTHORIZED	Current
55289-381	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
55289-409	Zoloft	sertraline hydrochloride	PD-Rx Pharmaceuticals, In	NDA	Current
55289-409	Zoloft	sertraline hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-409	Zoloft	sertraline hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-409	Zoloft	sertraline hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-409	Zoloft	sertraline hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-409	Zoloft	sertraline hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-409	Zoloft	sertraline hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
59762-4900	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4900	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4910	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-4960	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5160	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5160	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5160	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5160	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5160	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6347	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6347	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6347	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6347	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6347	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6443	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6443	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6443	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6443	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-6443	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
63629-6755	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-6755	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
67046-665	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Contract Pharmacy Services-PA	NDA	Current
67544-080	Zoloft	SERTRALINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
67544-298	Zoloft	SERTRALINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
70518-1913	Zoloft	sertraline hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1913	Zoloft	sertraline hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1913	Zoloft	sertraline hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1913	Zoloft	sertraline hydrochloride	REMEDYREPACK INC.	NDA	Current
71610-433	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
75921-490	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	Life Line Home Care Services	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75230	SUPPL	2023-08-22
75206	SUPPL	2023-08-22
75205	SUPPL	2023-08-22
73310	SUPPL	2023-01-30
73309	SUPPL	2023-01-30
73292	SUPPL	2023-01-26
68705	SUPPL	2021-09-21
68704	SUPPL	2021-09-21
68673	SUPPL	2021-09-21
50721	SUPPL	2017-12-18
50720	SUPPL	2017-12-18
50664	SUPPL	2017-12-12
50663	SUPPL	2017-12-12
50662	SUPPL	2017-12-12
48748	SUPPL	2017-06-16
48729	SUPPL	2017-06-16
46549	SUPPL	2016-12-27
46548	SUPPL	2016-12-27
46547	SUPPL	2016-12-27
46534	SUPPL	2016-12-27
46533	SUPPL	2016-12-27
46532	SUPPL	2016-12-27
11763	SUPPL	2014-09-19
19287	SUPPL	2014-09-16
11762	SUPPL	2014-07-08
11761	SUPPL	2014-07-08
1690	SUPPL	2014-07-08
1688	SUPPL	2014-07-08
34012	SUPPL	2013-02-06
19286	SUPPL	2013-02-04
34013	SUPPL	2012-12-28
34011	SUPPL	2012-12-28
1689	SUPPL	2012-12-21
1686	SUPPL	2012-12-21
34010	SUPPL	2011-08-24
11760	SUPPL	2011-08-24
11759	SUPPL	2011-08-24
19285	SUPPL	2011-08-22
19284	SUPPL	2011-08-22
1687	SUPPL	2011-08-22
11758	SUPPL	2009-02-04
19283	SUPPL	2009-02-03
19282	SUPPL	2008-03-07
11757	SUPPL	2008-03-07
34009	SUPPL	2007-10-10
1685	SUPPL	2007-10-10
19281	SUPPL	2007-08-07
1684	SUPPL	2007-08-07
1682	SUPPL	2007-08-07
34008	SUPPL	2007-08-03
34007	SUPPL	2007-08-03
20390	SUPPL	2007-03-02
34006	SUPPL	2006-09-15
11756	SUPPL	2006-09-15
1683	SUPPL	2006-09-15
1681	SUPPL	2006-09-15
1680	SUPPL	2006-05-16
23558	ORIG	2005-07-29
1679	SUPPL	2005-07-29
34005	SUPPL	2005-07-14
11755	SUPPL	2005-07-14
19280	SUPPL	2005-02-23
1678	SUPPL	2005-02-23
34004	SUPPL	2004-08-25
11754	SUPPL	2004-08-25
1677	SUPPL	2004-08-25
1676	SUPPL	2004-08-25
1675	SUPPL	2004-07-01
19279	SUPPL	2003-09-25
11752	SUPPL	2003-09-25
1671	SUPPL	2003-07-31
34001	SUPPL	2003-04-25
11753	SUPPL	2003-03-05
19278	SUPPL	2002-09-20
1674	SUPPL	2002-09-18
34003	SUPPL	2002-05-16
1673	SUPPL	2002-05-16
34002	SUPPL	2001-08-17
20389	SUPPL	2001-08-17
1672	SUPPL	2001-08-17
20388	SUPPL	1999-12-07
19277	SUPPL	1999-12-07
11751	SUPPL	1999-12-07
41058	SUPPL	1997-10-10
20387	SUPPL	1997-10-10
41057	SUPPL	1997-07-08
52192	SUPPL	1900-01-01
52191	SUPPL	1900-01-01
52190	SUPPL	1900-01-01
52189	SUPPL	1900-01-01