Application 204134

Type: ANDA
Sponsor: LUPIN LTD

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 12.5MG BASE	No	No
002	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 25MG BASE	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A204134-001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-01-20
A204134-002	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-01-20
A204134-003	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-01-20

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 4 · 123 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	A204134-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204134-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204134-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204134-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204134-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204134-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204134-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204134-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204134-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204134-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204134-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204134-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204134-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204134-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204134-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204134-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204134-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204134-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204134-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204134-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204134-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204134-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204134-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204134-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204134-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204134-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204134-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204134-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204134-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204134-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204134-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204134-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204134-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204134-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204134-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204134-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204134-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204134-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204134-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204134-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-01-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 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	A204134-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204134-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204134-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204134-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204134-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204134-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204134-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204134-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204134-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204134-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204134-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204134-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204134-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204134-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204134-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204134-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204134-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204134-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204134-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204134-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204134-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204134-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204134-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204134-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204134-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204134-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204134-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204134-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204134-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204134-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204134-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204134-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204134-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204134-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204134-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204134-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204134-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204134-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204134-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204134-001	AB	1	`8072bd15b7f6…`

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
PAROXETINE	PAROXETINE	Lupin Pharmaceuticals, Inc.	d315e0da-f829-408b-be5d-2bca2e06913c	2023-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204134 application number: ANDA204134 ndc (product): 68180-646 ndc (product): 68180-647 ndc (product): 68180-645

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68180-645	PAROXETINE	PAROXETINE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-645	PAROXETINE	PAROXETINE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-646	PAROXETINE	PAROXETINE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-646	PAROXETINE	PAROXETINE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-647	PAROXETINE	PAROXETINE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-647	PAROXETINE	PAROXETINE	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-3613	PAROXETINE	PAROXETINE	REMEDYREPACK INC.	ANDA	Current