Application 203854

Type: ANDA
Sponsor: PRINSTON INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAROXETINE	PAROXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	No	No
002	PAROXETINE	PAROXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 20MG BASE	No	No
003	PAROXETINE	PAROXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 30MG BASE	No	No
004	PAROXETINE	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
A203854-001	PAROXETINE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31
A203854-002	PAROXETINE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31
A203854-003	PAROXETINE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31
A203854-004	PAROXETINE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A203854-001	AB
A203854-002	AB
A203854-003	AB
A203854-004	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.

Product history page 1 of 5 · 164 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	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A203854-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203854-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203854-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203854-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203854-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203854-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203854-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203854-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203854-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203854-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203854-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203854-004	AB	1	`d06236e962d9…`

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	REMEDYREPACK INC.	88b4c469-19b3-44b9-a378-c7c3f4f436db	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854 ndc (product): 70518-2182
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	REMEDYREPACK INC.	4cb9dc05-adb8-4c88-ad40-af8c0df1cafd	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	REMEDYREPACK INC.	22174520-4b78-4841-96f7-530ba12d2cf1	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854 ndc (product): 70518-1253
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	REMEDYREPACK INC.	90c129a8-afce-4b8b-85d7-f89e6da2aef7	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854 ndc (product): 70518-2376
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	REMEDYREPACK INC.	009d8b89-eab9-43ba-b077-86bfa993a745	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	REMEDYREPACK INC.	28ddc9e0-05c5-482f-9371-60bbee451b33	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854 ndc (product): 70518-1406
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	NuCare Pharmaceuticals, Inc.	54efbbc1-4f5f-262d-e063-6394a90aadbc	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	NuCare Pharmaceuticals, Inc.	49dd0858-685f-f46b-e063-6294a90a7f39	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	NuCare Pharmaceuticals, Inc.	34909bfb-b4ad-25c4-e063-6294a90a0296	2025-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	PD-Rx Pharmaceuticals, Inc.	d551f3d0-9503-45bd-b701-dfed4c8a5e1e	2025-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	PD-Rx Pharmaceuticals, Inc.	65c81817-34d3-4c57-a4bf-fb10be98386d	2025-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Preferred Pharmaceuticals Inc.	91c5a321-e174-4d86-9a84-e5e278d45aff	2025-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Solco Healthcare US, LLC	6cfde064-ddcb-49df-a53c-953c40eb1470	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854 ndc (product): 43547-347 ndc (product): 43547-348 ndc (product): 43547-350 ndc (product): 43547-349
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Bryant Ranch Prepack	ac6ea24f-a9f3-4413-8c3a-9e2e4ca93c0f	2024-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Proficient Rx LP	ce168c41-a860-45f5-bae8-7b3d9b48d86a	2024-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Proficient Rx LP	903e4ef1-487d-4b65-9038-b05ceaf74d19	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	A-S Medication Solutions	525884d7-e2ee-4d57-a6c9-bd129e9fb9d0	2023-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854 ndc (product): 50090-5987
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	NCS HealthCare of KY, LLC dba Vangard Labs	c3b2ce88-6f09-4f7b-ac73-93dca84aa3b8	2022-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854 ndc (product): 0615-8174 ndc (product): 0615-7985 ndc (product): 0615-8173
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Proficient Rx LP	8526c68d-221c-4822-9532-1d7868cff35e	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854 ndc (product): 63187-927

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 104 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7985	Paroxetine	paroxetine hydrochloride hemihydrate	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-7985	Paroxetine	paroxetine hydrochloride hemihydrate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7985	Paroxetine	paroxetine hydrochloride hemihydrate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8173	Paroxetine	Paroxetine	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8173	Paroxetine	Paroxetine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8173	Paroxetine	Paroxetine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8174	Paroxetine	Paroxetine	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8174	Paroxetine	Paroxetine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8174	Paroxetine	Paroxetine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43547-347	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-347	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-347	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-347	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-348	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-348	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-348	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-348	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-349	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-349	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-349	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-349	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-350	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-350	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-350	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
43547-350	Paroxetine	paroxetine hydrochloride hemihydrate	Solco Healthcare US, LLC	ANDA	Current
50090-4207	Paroxetine	paroxetine hydrochloride hemihydrate	A-S Medication Solutions	ANDA	Current
50090-4207	Paroxetine	paroxetine hydrochloride hemihydrate	A-S Medication Solutions	ANDA	Current
50090-4838	Paroxetine	paroxetine hydrochloride hemihydrate	A-S Medication Solutions	ANDA	Current
50090-5987	Paroxetine	paroxetine hydrochloride hemihydrate	A-S Medication Solutions	ANDA	Current
52817-140	Paroxetine	paroxetine hydrochloride	Trupharma, LLC	ANDA	Current
52817-141	Paroxetine	paroxetine hydrochloride	Trupharma, LLC	ANDA	Current
52817-142	Paroxetine	paroxetine hydrochloride	Trupharma, LLC	ANDA	Current
52817-143	Paroxetine	paroxetine hydrochloride	Trupharma, LLC	ANDA	Current
53002-2174	Paroxetine	paroxetine hydrochloride hemihydrate	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-379	Paroxetine	paroxetine hydrochloride hemihydrate	Lake Erie Medical DBA Qua	ANDA	Current
55700-379	Paroxetine	paroxetine hydrochloride hemihydrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-379	Paroxetine	paroxetine hydrochloride hemihydrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-379	Paroxetine	paroxetine hydrochloride hemihydrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-503	Paroxetine	paroxetine hydrochloride hemihydrate	Lake Erie Medical DBA Qua	ANDA	Current
55700-503	Paroxetine	paroxetine hydrochloride hemihydrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-503	Paroxetine	paroxetine hydrochloride hemihydrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-503	Paroxetine	paroxetine hydrochloride hemihydrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63187-927	Paroxetine	paroxetine hydrochloride hemihydrate	Proficient Rx LP	ANDA	Current
63187-927	Paroxetine	paroxetine hydrochloride hemihydrate	Proficient Rx LP	ANDA	Current
63187-927	Paroxetine	paroxetine hydrochloride hemihydrate	Proficient Rx LP	ANDA	Current
63187-927	Paroxetine	paroxetine hydrochloride hemihydrate	Proficient Rx LP	ANDA	Current
68071-3278	Paroxetine	paroxetine hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-6977	Paroxetine	paroxetine hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6985	Paroxetine	paroxetine hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7677	Paroxetine	paroxetine hydrochloride hemihydrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7677	Paroxetine	paroxetine hydrochloride hemihydrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0320	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-0320	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-0550	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-0550	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-0550	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-0550	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-0550	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-0550	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-1210	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-1210	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-1253	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-1253	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-1253	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-1253	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-1284	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-1284	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-1406	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-1406	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-1406	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-1406	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-2182	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-2182	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-2182	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-2182	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-2182	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-2376	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-2376	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-2376	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-2376	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current