Application 020031

Type: NDA
Sponsor: APOTEX TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAXIL	PAROXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	Yes	No
002	PAXIL	PAROXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 20MG BASE	Yes	No
003	PAXIL	PAROXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 30MG BASE	Yes	No
004	PAXIL	PAROXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 50MG BASE	No	No
005	PAXIL	PAROXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 40MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020031-001	PAXIL	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1992-12-29
N020031-002	PAXIL	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1992-12-29
N020031-003	PAXIL	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1992-12-29
N020031-004	PAXIL	PAROXETINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL			1992-12-29
N020031-005	PAXIL	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	1992-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N020031-001	AB
N020031-002	AB
N020031-003	AB
N020031-005	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 1 of 6 · 210 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	N020031-001	PAXIL	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020031-002	PAXIL	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020031-003	PAXIL	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020031-004	PAXIL	EQ 50MG BASE	TABLET / ORAL			1992-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020031-005	PAXIL	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	1992-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020031-001	PAXIL	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020031-002	PAXIL	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020031-003	PAXIL	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020031-004	PAXIL	EQ 50MG BASE	TABLET / ORAL			1992-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020031-005	PAXIL	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	1992-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020031-001	PAXIL	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020031-002	PAXIL	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020031-003	PAXIL	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020031-004	PAXIL	EQ 50MG BASE	TABLET / ORAL			1992-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020031-005	PAXIL	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	1992-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020031-001	PAXIL	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020031-002	PAXIL	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020031-003	PAXIL	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020031-004	PAXIL	EQ 50MG BASE	TABLET / ORAL			1992-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020031-005	PAXIL	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	1992-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020031-001	PAXIL	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020031-002	PAXIL	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020031-003	PAXIL	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020031-004	PAXIL	EQ 50MG BASE	TABLET / ORAL			1992-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020031-005	PAXIL	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	1992-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020031-001	PAXIL	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020031-002	PAXIL	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020031-003	PAXIL	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020031-004	PAXIL	EQ 50MG BASE	TABLET / ORAL			1992-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020031-005	PAXIL	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	1992-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020031-001	PAXIL	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020031-002	PAXIL	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020031-003	PAXIL	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020031-004	PAXIL	EQ 50MG BASE	TABLET / ORAL			1992-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020031-005	PAXIL	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	1992-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020031-001	PAXIL	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020031-002	PAXIL	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020031-003	PAXIL	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1992-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020031-004	PAXIL	EQ 50MG BASE	TABLET / ORAL			1992-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020031-005	PAXIL	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	1992-12-29	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	N020031-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020031-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020031-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020031-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020031-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020031-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020031-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020031-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020031-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020031-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020031-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020031-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020031-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020031-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020031-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020031-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020031-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020031-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020031-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020031-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020031-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020031-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020031-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020031-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020031-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020031-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020031-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020031-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020031-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020031-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020031-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020031-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020031-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020031-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020031-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020031-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020031-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020031-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020031-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020031-005	AB	1	`d8e5a09893c0…`

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
PAXIL	PAROXETINE HYDROCHLORIDE	Apotex Corp	ef3b5cbe-f9e1-c1ac-79da-cfe14e3a7e7e	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020031 application number: NDA020031 ndc (product): 60505-4520 ndc (product): 60505-4518 ndc (product): 60505-4517 ndc (product): 60505-4519

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-3663	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3663	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3663	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3664	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3664	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3664	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3665	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3665	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3665	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3666	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3666	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3666	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-3666	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4517	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4517	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4517	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4517	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4517	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4518	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4518	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4518	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4518	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4518	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4519	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4519	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4519	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4519	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4519	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4520	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4520	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4520	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4520	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
60505-4520	PAXIL	paroxetine hydrochloride	Apotex Corp	NDA	Current
70518-2500	PAXIL	paroxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2636	PAXIL	paroxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2636	PAXIL	paroxetine hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2636	PAXIL	paroxetine hydrochloride	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80479	SUPPL	2024-12-03
80457	SUPPL	2024-12-02
80456	SUPPL	2024-12-02
76590	SUPPL	2023-11-16
68842	SUPPL	2021-10-01
68841	SUPPL	2021-10-01
69745	SUPPL	2021-09-30
68726	SUPPL	2021-09-23
66182	SUPPL	2021-02-11
66181	SUPPL	2021-02-11
66134	SUPPL	2021-02-09
46812	SUPPL	2017-01-13
46811	SUPPL	2017-01-13
46694	SUPPL	2017-01-06
12148	SUPPL	2014-07-29
1926	SUPPL	2014-07-23
41125	SUPPL	2014-01-16
34190	SUPPL	2012-12-31
1925	SUPPL	2012-12-21
34191	SUPPL	2012-04-17
21056	SUPPL	2012-04-12
34189	SUPPL	2011-07-12
34186	SUPPL	2011-07-12
1924	SUPPL	2011-07-12
1919	SUPPL	2011-07-12
34192	SUPPL	2011-03-28
12147	SUPPL	2011-03-28
12146	SUPPL	2011-03-28
21057	SUPPL	2011-03-24
1923	SUPPL	2011-03-24
1921	SUPPL	2011-03-24
1922	SUPPL	2010-11-02
34188	SUPPL	2010-10-28
1920	SUPPL	2009-11-19
12144	SUPPL	2009-11-05
34187	SUPPL	2009-02-04
21055	SUPPL	2009-02-03
12145	SUPPL	2008-11-07
21054	SUPPL	2008-11-03
1918	SUPPL	2007-08-07
12143	SUPPL	2007-08-03
41124	SUPPL	2007-07-09
41123	SUPPL	2007-07-09
41122	SUPPL	2007-07-09
20454	SUPPL	2007-07-09
20453	SUPPL	2007-07-09
19951	SUPPL	2006-09-25
19950	SUPPL	2006-09-25
19947	SUPPL	2006-09-25
19946	SUPPL	2006-03-23
19949	SUPPL	2006-02-08
19948	SUPPL	2006-02-08
1917	SUPPL	2006-02-08
44042	ORIG	2005-08-16
1915	SUPPL	2005-07-15
19945	SUPPL	2005-01-13
12142	SUPPL	2005-01-13
20455	SUPPL	2004-09-15
20452	SUPPL	2004-06-29
1916	SUPPL	2004-05-27
19944	SUPPL	2004-04-20
19943	SUPPL	2004-04-20
34184	SUPPL	2003-04-24
19942	SUPPL	2002-10-02
34185	SUPPL	2001-12-14
19941	SUPPL	2001-12-14
19940	SUPPL	2001-04-13
12141	SUPPL	2001-04-13
1914	SUPPL	1999-05-11
53124	ORIG	1900-01-01
53123	ORIG	1900-01-01
53122	ORIG	1900-01-01
53121	ORIG	1900-01-01