Application 091427

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 37.5MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091427-001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2011-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091427-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091427-001	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-04-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091427-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091427-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091427-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091427-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091427-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091427-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091427-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091427-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091427-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091427-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091427-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091427-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091427-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091427-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091427-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091427-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091427-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091427-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091427-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091427-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091427-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091427-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091427-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091427-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091427-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091427-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091427-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091427-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091427-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091427-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091427-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091427-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091427-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091427-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091427-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091427-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091427-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091427-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091427-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091427-001	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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	REMEDYREPACK INC.	8e176ff2-ed3a-4909-94e1-6b9a3581a621	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
PAROXETINE	PAROXETINE HYDROCHLORIDE	REMEDYREPACK INC.	beb87e2e-0a8f-43b6-b148-57f0b7191548	2026-07-02	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 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	REMEDYREPACK INC.	98d4f767-06e3-4d9b-b1ad-4b31f7e36130	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
PAXIL CR	PAROXETINE HYDROCHLORIDE	Apotex Corp	483bd97f-c4d0-4e23-aaa8-6334f4471e0c	2025-09-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	Apotex Corp	087ff0d3-1761-47ea-a8c1-7c4cb679af97	2025-09-22	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	2025-09-05	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	Major Pharmaceuticals	84b1b1f0-d375-4fda-99af-9487f8ef50c7	2025-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PAROXETINE HYDROCHLORIDE
PAROXETINE	PAROXETINE HYDROCHLORIDE	Apotex Corp.	08320ea3-8f93-6f04-5d1c-f69af3eb5a81	2025-07-24	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
PAXIL	PAROXETINE HYDROCHLORIDE	Apotex Corp	ef3b5cbe-f9e1-c1ac-79da-cfe14e3a7e7e	2024-10-22	Boxed warning, Warnings, Adverse reactions	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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2005	Paroxetine Hydrochloride	paroxetine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2005	Paroxetine Hydrochloride	paroxetine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2005	Paroxetine Hydrochloride	paroxetine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2005	Paroxetine Hydrochloride	paroxetine hydrochloride	Mylan Pharmaceuticals Inc	ANDA	Current
0378-2005	Paroxetine Hydrochloride	paroxetine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2005	Paroxetine Hydrochloride	paroxetine hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current