Application 020936

Type: NDA
Sponsor: APOTEX TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAXIL CR	PAROXETINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 12.5MG BASE	Yes	No
002	PAXIL CR	PAROXETINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 25MG BASE	Yes	No
003	PAXIL CR	PAROXETINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 37.5MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
N020936-001	PAXIL CR	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16
N020936-002	PAXIL CR	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16
N020936-003	PAXIL CR	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020936-001	AB
N020936-002	AB
N020936-003	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 · 129 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
2026-09-14 22:38:34	2026-08	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-002	PAXIL CR	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-003	PAXIL CR	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020936-001	PAXIL CR	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1999-02-16	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N020936-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020936-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020936-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020936-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020936-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020936-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020936-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020936-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020936-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020936-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020936-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020936-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020936-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020936-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020936-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020936-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020936-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020936-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020936-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020936-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020936-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020936-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020936-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020936-001	AB	1	`301d65b070ca…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paroxetine	PAROXETINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc	605c1d23-c97c-4ea4-92d0-fed351de9d2e	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
Paroxetine	PAROXETINE HYDROCHLORIDE	NorthStar Rx LLC	118320de-0632-4139-8b13-7428b41da0ac	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
PAROXETINE	PAROXETINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	e63fe922-b35a-406c-8737-f3f5e6d5a30d	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	26d37a39-1c53-461c-8834-c67fbffcfe99	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
PAROXETINE	PAROXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4d3b4536-7900-223c-e063-6294a90a3d60	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
PAROXETINE	PAROXETINE HYDROCHLORIDE	REMEDYREPACK INC.	98d4f767-06e3-4d9b-b1ad-4b31f7e36130	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
PAROXETINE	PAROXETINE HYDROCHLORIDE	Cardinal Health 107, LLC	333dfd07-61f0-4b86-b4b5-b04adf64e49f	2025-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
Paroxetine	PAROXETINE HYDROCHLORIDE	Aurobindo Pharma Limited	326e8ab0-6886-4749-9544-885b37070051	2025-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
Paroxetine	PAROXETINE HYDROCHLORIDE	Zydus Lifesciences Limited	6d5fcdb2-4d84-4b20-87e3-58a43e567500	2024-12-03		Name fallback generic name: PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride	PAROXETINE HYDROCHLORIDE	Bryant Ranch Prepack	c3c204df-6b7d-42fb-8794-4f38064ed963	2024-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride	PAROXETINE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	25182b68-8f7a-48e8-9788-6818b0984b29	2024-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
Paroxetine Hydrochloride	PAROXETINE HYDROCHLORIDE	Bryant Ranch Prepack	5e47c4fb-6070-4cb4-acaa-c6e90199b55c	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
Paroxetine Hydrochloride	PAROXETINE HYDROCHLORIDE	Lannett Company, Inc.	f22886f5-230c-47e4-9dd8-ffb14c8d6ae4	2023-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
PAROXETINE	PAROXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1801246b-02c3-430f-932a-b18cb0d13d1d	2018-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
PAROXETINE	PAROXETINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	a7128be7-7023-40c4-aa64-29d52145ae31	2018-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE 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 2 · 83 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-159	PAXIL	paroxetine hydrochloride	Rebel Distributors Corp	NDA	Current
21695-160	PAXIL	paroxetine hydrochloride	Rebel Distributors Corp	NDA	Current
60505-1316	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1316	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1316	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1316	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1316	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1317	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1317	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1317	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1317	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1317	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1318	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1318	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1318	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1318	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-1318	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3668	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3668	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3668	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3668	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3668	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3668	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3668	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3669	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3669	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3669	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3669	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3669	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3669	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3669	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3670	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3670	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3670	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3670	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3670	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3670	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3670	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3673	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3673	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3673	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3673	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3673	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3674	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3674	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3674	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3674	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3674	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3674	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3675	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3675	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3675	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3675	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3675	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3675	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4377	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4377	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4377	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4377	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4377	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4377	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4377	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4378	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4378	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4378	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4378	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4378	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4378	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4378	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4379	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4379	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4379	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4379	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4379	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4379	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4379	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
63629-4615	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	Bryant Ranch Prepack	NDA	Current
70518-1791	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1791	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
71335-0572	PAXIL	paroxetine hydrochloride	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77632	SUPPL	2024-02-27
77623	SUPPL	2024-02-26
75228	SUPPL	2023-08-22
75227	SUPPL	2023-08-22
75213	SUPPL	2023-08-22
75212	SUPPL	2023-08-22
75211	SUPPL	2023-08-22
68838	SUPPL	2021-10-01
68837	SUPPL	2021-10-01
68728	SUPPL	2021-09-23
59985	SUPPL	2019-09-12
59984	SUPPL	2019-09-12
59979	SUPPL	2019-09-12
46815	SUPPL	2017-01-13
46696	SUPPL	2017-01-06
35672	SUPPL	2014-07-30
3804	SUPPL	2014-07-23
35671	SUPPL	2012-12-31
26239	SUPPL	2012-12-21
13776	SUPPL	2012-04-17
3803	SUPPL	2012-04-12
41823	SUPPL	2011-12-09
41822	SUPPL	2011-12-09
21287	SUPPL	2011-12-09
21286	SUPPL	2011-12-09
21285	SUPPL	2011-12-09
21284	SUPPL	2011-12-09
13775	SUPPL	2011-07-12
13771	SUPPL	2011-07-12
3802	SUPPL	2011-07-12
3796	SUPPL	2011-07-12
13774	SUPPL	2011-03-28
13773	SUPPL	2011-03-28
3801	SUPPL	2011-03-24
3800	SUPPL	2011-03-24
26238	SUPPL	2010-11-02
35670	SUPPL	2010-10-28
26237	SUPPL	2009-11-19
3797	SUPPL	2009-11-19
35668	SUPPL	2009-11-05
35669	SUPPL	2009-02-04
3799	SUPPL	2009-02-03
13772	SUPPL	2008-11-07
3798	SUPPL	2008-11-03
3794	SUPPL	2007-08-07
41824	SUPPL	2007-08-06
35667	SUPPL	2007-08-03
21289	SUPPL	2007-07-06
26236	SUPPL	2006-09-20
3795	SUPPL	2006-09-20
3792	SUPPL	2006-09-20
26233	SUPPL	2006-03-23
26235	SUPPL	2006-02-08
26234	SUPPL	2006-02-08
3793	SUPPL	2006-02-08
23611	ORIG	2005-08-01
3789	SUPPL	2005-07-15
13770	SUPPL	2005-01-13
3791	SUPPL	2005-01-13
3790	SUPPL	2004-05-27
35666	SUPPL	2004-02-03
26232	SUPPL	2004-02-02
13769	SUPPL	2003-10-17
3788	SUPPL	2003-10-17
26231	SUPPL	2003-09-09
13768	SUPPL	2003-09-09
35665	SUPPL	2002-02-12
26230	SUPPL	2002-02-12
21288	SUPPL	2002-02-12
41821	ORIG	1999-02-16
26229	ORIG	1999-02-16
13767	ORIG	1999-02-16