Application 076968

Type: ANDA
Sponsor: OXFORD PHARMS

Application Products#

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

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

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	Approval date
A076968-001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2010-06-21
A076968-002	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2010-06-21
A076968-003	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2010-06-21
A076968-004	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2010-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076968-001	AB
A076968-002	AB
A076968-003	AB
A076968-004	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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076968-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2010-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076968-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2010-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076968-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2010-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076968-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2010-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076968-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2010-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076968-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2010-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076968-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2010-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076968-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2010-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076968-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2010-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076968-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2010-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076968-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2010-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076968-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2010-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076968-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2010-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076968-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2010-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076968-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2010-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076968-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2010-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076968-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2010-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076968-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2010-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076968-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2010-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076968-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2010-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076968-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2010-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076968-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2010-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076968-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2010-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076968-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2010-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076968-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2010-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076968-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2010-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076968-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2010-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076968-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2010-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076968-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2010-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076968-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2010-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076968-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2010-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076968-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2010-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076968-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2010-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076968-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2010-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076968-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2010-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076968-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2010-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076968-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2010-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076968-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2010-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076968-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2010-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076968-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2010-06-21	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A076968-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076968-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076968-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076968-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076968-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076968-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076968-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076968-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076968-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076968-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076968-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076968-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076968-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076968-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076968-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076968-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076968-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076968-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076968-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076968-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076968-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076968-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076968-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076968-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076968-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076968-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076968-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076968-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076968-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076968-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076968-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076968-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076968-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076968-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076968-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076968-004	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076968-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076968-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076968-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076968-004	AB	1	`6a51e52b5d6a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
paroxetine hydrochloride	PAROXETINE HYDROCHLORIDE	Bryant Ranch Prepack	c3c204df-6b7d-42fb-8794-4f38064ed963	2024-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076968 application number: ANDA076968
paroxetine hydrochloride	PAROXETINE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	25182b68-8f7a-48e8-9788-6818b0984b29	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076968 application number: ANDA076968 ndc (product): 69584-672 ndc (product): 69584-673 ndc (product): 69584-671 ndc (product): 69584-674

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69584-671	paroxetine hydrochloride	paroxetine hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-672	paroxetine hydrochloride	paroxetine hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-673	paroxetine hydrochloride	paroxetine hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-674	paroxetine hydrochloride	paroxetine hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current