Application 090781

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.125MG	No	No
002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.25MG	No	No
003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.5MG	No	No
004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	1MG	No	No
005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	1.5MG	No	No
006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.75MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08
A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08
A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08
A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08
A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08
A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A090781-001	AB
A090781-002	AB
A090781-003	AB
A090781-004	AB
A090781-005	AB
A090781-006	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A090781-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090781-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090781-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090781-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090781-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090781-006	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	44c336d2-01d1-4f13-bad9-549cdc3505ec	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090781 application number: ANDA090781 ndc (product): 68462-332 ndc (product): 68462-330 ndc (product): 68462-334 ndc (product): 68462-331 ndc (product): 68462-333 ndc (product): 68462-627
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	5e6f2187-a5cc-481e-b0a1-d38d3f92e822	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090781 application number: ANDA090781

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2190	Pramipexole dihydrochloride	Pramipexole dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-2190	Pramipexole dihydrochloride	Pramipexole dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-2190	Pramipexole dihydrochloride	Pramipexole dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-2217	Pramipexole dihydrochloride	Pramipexole dihydrochloride	A-S Medication Solutions	ANDA	Current
68462-330	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-330	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-330	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-330	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-331	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-331	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-331	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-331	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-332	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-332	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-332	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-332	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-333	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-333	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-333	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-333	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-334	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-334	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-334	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-334	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-627	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-627	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-627	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-627	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
70934-596	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current