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 42.

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.

Product history page 1 of 7 · 252 observed 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
2026-08-18 06:07:40	2026-07	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB		2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB		2015-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB		2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	RS	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB		2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB		2010-10-08	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 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	A090781-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090781-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090781-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090781-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090781-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090781-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090781-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090781-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090781-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090781-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090781-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090781-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090781-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090781-004	AB	1	`03ed91905a0d…`

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 · 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