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 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A076968-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2010-06-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076968-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2010-06-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076968-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2010-06-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076968-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2010-06-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A076968-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076968-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076968-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076968-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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