Application 020710

Type: NDA
Sponsor: APOTEX TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAXIL	PAROXETINE HYDROCHLORIDE	SUSPENSION;ORAL	EQ 10MG BASE/5ML	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020710-001	PAXIL	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD	1997-06-25

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 2 · 43 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	N020710-001	PAXIL	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD	1997-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020710-001	PAXIL	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD	1997-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD	1997-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD	1997-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD	1997-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD	1997-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD	1997-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD	1997-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD	1997-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD, RS	1997-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD, RS	1997-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD, RS	1997-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD, RS	1997-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD, RS	1997-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD, RS	1997-06-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD, RS	1997-06-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RLD, RS	1997-06-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020710-001	PAXIL	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RLD, RS	1997-06-25	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020710-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020710-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020710-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020710-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020710-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020710-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020710-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020710-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020710-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020710-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N020710-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020710-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020710-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020710-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020710-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020710-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020710-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020710-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020710-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020710-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020710-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020710-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020710-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020710-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020710-001	AB	1	`cb3db0bc1861…`

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 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-0402	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-0402	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-0402	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-0402	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-0402	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-0402	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-0402	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80480	SUPPL	2024-12-03
80459	SUPPL	2024-12-02
80458	SUPPL	2024-12-02
68844	SUPPL	2021-10-01
68843	SUPPL	2021-10-01
68727	SUPPL	2021-09-23
66804	SUPPL	2021-03-18
66803	SUPPL	2021-03-18
66135	SUPPL	2021-02-09
46814	SUPPL	2017-01-13
46813	SUPPL	2017-01-13
46695	SUPPL	2017-01-06
13262	SUPPL	2014-07-29
25596	SUPPL	2014-07-23
13260	SUPPL	2012-12-31
3161	SUPPL	2012-12-21
35194	SUPPL	2012-04-17
3162	SUPPL	2012-04-12
41603	SUPPL	2011-12-09
41602	SUPPL	2011-12-09
41601	SUPPL	2011-12-09
13259	SUPPL	2011-07-12
13258	SUPPL	2011-07-12
3160	SUPPL	2011-07-12
3156	SUPPL	2011-07-12
35193	SUPPL	2011-03-28
35191	SUPPL	2011-03-28
13261	SUPPL	2011-03-28
25595	SUPPL	2011-03-24
3159	SUPPL	2011-03-24
3158	SUPPL	2011-03-24
25594	SUPPL	2010-11-02
35192	SUPPL	2010-10-28
25592	SUPPL	2009-11-19
35188	SUPPL	2009-11-05
35190	SUPPL	2009-02-04
25593	SUPPL	2009-02-03
35189	SUPPL	2008-11-07
3157	SUPPL	2008-11-03
41600	SUPPL	2007-09-24
41599	SUPPL	2007-09-24
20867	SUPPL	2007-09-24
25590	SUPPL	2007-08-07
35187	SUPPL	2007-08-03
25591	SUPPL	2006-09-20
3155	SUPPL	2006-09-20
25589	SUPPL	2006-02-08
3154	SUPPL	2006-02-08
44067	ORIG	2005-08-01