Application 078026

Type: ANDA
Sponsor: ROXANE

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 44.

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	Approval date
A078026-001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29
A078026-002	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29
A078026-003	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29
A078026-004	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078026-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078026-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078026-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078026-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078026-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078026-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078026-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078026-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078026-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078026-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078026-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078026-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078026-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078026-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078026-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078026-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078026-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078026-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078026-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078026-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078026-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078026-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078026-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078026-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078026-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078026-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078026-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078026-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078026-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078026-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078026-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078026-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078026-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078026-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078026-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078026-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078026-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-06-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078026-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-06-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078026-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2007-06-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078026-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-06-29	`ea99ee380514…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	Apotex Corp	087ff0d3-1761-47ea-a8c1-7c4cb679af97	2026-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PAROXETINE HYDROCHLORIDE generic name: PAROXETINE HYDROCHLORIDE
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 HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	26d37a39-1c53-461c-8834-c67fbffcfe99	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PAROXETINE HYDROCHLORIDE 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	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 brand name: paroxetine hydrochloride 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 brand name: paroxetine hydrochloride 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 brand name: Paroxetine Hydrochloride 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 brand name: Paroxetine Hydrochloride 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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23892	ORIG	2007-07-05