Application 078902

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;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 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
A078902-001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-03-13
A078902-002	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2008-03-13
A078902-003	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2008-03-13
A078902-004	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2008-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078902-001	AB
A078902-002	AB
A078902-003	AB
A078902-004	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	A078902-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078902-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2008-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078902-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2008-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078902-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2008-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078902-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078902-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2008-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078902-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2008-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078902-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2008-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078902-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078902-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2008-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078902-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2008-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078902-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2008-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078902-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078902-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2008-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078902-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2008-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078902-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2008-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078902-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078902-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2008-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078902-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2008-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078902-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2008-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078902-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078902-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2008-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078902-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2008-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078902-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2008-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078902-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078902-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2008-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078902-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2008-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078902-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2008-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078902-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078902-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2008-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078902-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2008-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078902-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2008-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078902-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078902-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2008-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078902-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2008-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078902-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2008-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078902-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-03-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078902-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2008-03-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078902-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2008-03-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078902-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2008-03-13	`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	A078902-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078902-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078902-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078902-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078902-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078902-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078902-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078902-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078902-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078902-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078902-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078902-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078902-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078902-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078902-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078902-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078902-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078902-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078902-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078902-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078902-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078902-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078902-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078902-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078902-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078902-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078902-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078902-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078902-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078902-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078902-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078902-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078902-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078902-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078902-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078902-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078902-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078902-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078902-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078902-004	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	PD-Rx Pharmaceuticals, Inc.	619e10bb-6e5d-4ec3-a85a-6270965f5389	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078902 application number: ANDA078902 ndc (product): 55289-053
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	PD-Rx Pharmaceuticals, Inc.	ff7c7e20-c9ee-4693-beaa-7ac532d5c4b7	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078902 application number: ANDA078902 ndc (product): 55289-037
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Mylan Pharmaceuticals Inc.	89dd7e24-85fc-4152-89ea-47ec2b48a1ed	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078902 application number: ANDA078902 ndc (product): 0378-7003 ndc (product): 0378-7002 ndc (product): 0378-7004 ndc (product): 0378-7001
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Preferred Pharmaceuticals Inc.	2b2e6cd0-d779-4b7b-b3aa-85b796874ac3	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078902 application number: ANDA078902
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Aphena Pharma Solutions - Tennessee, LLC	ec9622ca-1f56-4216-9445-485791c4c0ed	2020-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078902 application number: ANDA078902 ndc (product): 43353-544 ndc (product): 43353-554
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Aphena Pharma Solutions - Tennessee, LLC	45ef7ce8-5aa0-488c-a81c-cdfbda66ac04	2019-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078902 application number: ANDA078902 ndc (product): 71610-243
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Aphena Pharma Solutions - Tennessee, LLC	2eebd2b6-7c64-45ca-8eb5-5201137f610a	2018-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078902 application number: ANDA078902 ndc (product): 71610-204

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-7001	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7001	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7001	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7001	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7002	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7002	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7002	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7002	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7003	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7003	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7003	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7003	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7004	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7004	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7004	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7004	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Pharmaceuticals Inc.	ANDA	Current
43063-170	Paroxetine	paroxetine hydrochloride hemihydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-544	Paroxetine	paroxetine hydrochloride hemihydrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-544	Paroxetine	paroxetine hydrochloride hemihydrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-544	Paroxetine	paroxetine hydrochloride hemihydrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-554	Paroxetine	paroxetine hydrochloride hemihydrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-554	Paroxetine	paroxetine hydrochloride hemihydrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-554	Paroxetine	paroxetine hydrochloride hemihydrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-774	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Institutional Inc.	ANDA	Current
51079-774	Paroxetine	paroxetine hydrochloride hemihydrate	Mylan Institutional Inc.	ANDA	Current
53808-0393	Paroxetine	Paroxetine hydrochloride hemihydrate	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0394	Paroxetine	Paroxetine hydrochloride hemihydrate	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0601	Paroxetine	Paroxetine hydrochloride hemihydrate	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0655	Paroxetine	Paroxetine hydrochloride hemihydrate	State of Florida DOH Central Pharmacy	ANDA	Current
55154-5087	Paroxetine	Paroxetine hydrochloride hemihydrate	Cardinal Health	ANDA	Current
55154-5087	Paroxetine	Paroxetine hydrochloride hemihydrate	Cardinal Health	ANDA	Current
55289-037	Paroxetine	paroxetine hydrochloride hemihydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-037	Paroxetine	paroxetine hydrochloride hemihydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-037	Paroxetine	paroxetine hydrochloride hemihydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-037	Paroxetine	paroxetine hydrochloride hemihydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-037	Paroxetine	paroxetine hydrochloride hemihydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-037	Paroxetine	paroxetine hydrochloride hemihydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-053	Paroxetine	paroxetine hydrochloride hemihydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-053	Paroxetine	paroxetine hydrochloride hemihydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-053	Paroxetine	paroxetine hydrochloride hemihydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-053	Paroxetine	paroxetine hydrochloride hemihydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-053	Paroxetine	paroxetine hydrochloride hemihydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
58517-160	paroxetine hydrochloride	paroxetine hydrochloride	New Horizon Rx Group, LLC	ANDA	Current
70518-1658	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
70518-1658	Paroxetine	paroxetine hydrochloride hemihydrate	REMEDYREPACK INC.	ANDA	Current
71610-204	Paroxetine	paroxetine hydrochloride hemihydrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-243	Paroxetine	paroxetine hydrochloride hemihydrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44397	ORIG	2008-03-21