Application 204744

Type: ANDA
Sponsor: LANNETT CO INC

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 42.

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	TE codes	Approval date
A204744-001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10
A204744-002	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10
A204744-003	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204744-001	AB
A204744-002	AB
A204744-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A204744-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204744-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204744-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204744-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204744-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204744-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204744-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204744-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204744-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204744-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204744-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204744-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204744-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204744-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204744-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204744-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204744-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204744-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204744-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204744-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204744-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204744-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204744-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204744-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204744-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204744-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204744-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204744-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204744-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204744-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204744-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204744-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204744-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204744-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204744-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204744-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204744-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204744-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204744-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204744-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-10	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204744-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204744-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204744-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204744-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204744-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204744-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204744-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204744-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204744-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204744-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204744-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204744-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204744-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204744-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204744-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204744-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204744-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204744-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204744-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204744-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204744-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204744-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204744-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204744-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204744-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204744-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204744-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204744-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204744-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204744-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204744-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204744-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204744-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204744-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204744-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204744-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204744-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204744-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204744-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204744-001	AB	1	`1e350fbaab3a…`

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 · 3 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	5e47c4fb-6070-4cb4-acaa-c6e90199b55c	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204744 application number: ANDA204744 ndc (product): 63629-8527
Paroxetine Hydrochloride	PAROXETINE HYDROCHLORIDE	Lannett Company, Inc.	f22886f5-230c-47e4-9dd8-ffb14c8d6ae4	2023-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204744 application number: ANDA204744 ndc (product): 62175-472 ndc (product): 62175-470 ndc (product): 62175-471
Paroxetine	PAROXETINE	Chartwell RX, LLC	52c3c5c4-6434-4f95-b5f0-9ecfdc0a7e0a	2022-12-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204744 application number: ANDA204744 ndc (product): 62135-426 ndc (product): 62135-425 ndc (product): 62135-427

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62135-425	Paroxetine	Paroxetine	Chartwell RX, LLC	ANDA	Current
62135-426	Paroxetine	Paroxetine	Chartwell RX, LLC	ANDA	Current
62135-427	Paroxetine	Paroxetine	Chartwell RX, LLC	ANDA	Current
62175-470	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
62175-470	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
62175-470	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Kremers Urban Pharmaceuticals Inc.	ANDA	Current
62175-470	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
62175-470	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
62175-470	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
62175-471	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
62175-471	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
62175-471	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Kremers Urban Pharmaceuticals Inc.	ANDA	Current
62175-471	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
62175-471	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
62175-471	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
62175-472	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
62175-472	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
62175-472	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Kremers Urban Pharmaceuticals Inc.	ANDA	Current
62175-472	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
62175-472	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
62175-472	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Lannett Company, Inc.	ANDA	Current
63629-8527	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8527	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8527	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
70518-2118	Paroxetine Hydrochloride	Paroxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2118	Paroxetine Hydrochloride	Paroxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2118	Paroxetine Hydrochloride	Paroxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2118	Paroxetine Hydrochloride	Paroxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2118	Paroxetine Hydrochloride	Paroxetine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-1205	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1205	Paroxetine Hydrochloride	Paroxetine Hydrochloride	Bryant Ranch Prepack	ANDA	Current