Application 090190

Type: ANDA
Sponsor: SANDOZ

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 43.

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	Approval date
A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06
A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06
A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06
A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06
A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06
A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08

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 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`b8a1b40f171c…`

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 2 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	b978aa75-c62d-444b-9ec6-6c0d21a66688	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: pramipexole dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Aurobindo Pharma Limited	3f90971a-e005-4dd3-bb93-b09125ada3c8	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Strides Pharma Science Limited	fb2260d6-204c-4d25-a331-0f8340d83a6e	2025-08-17	Warnings, Adverse reactions	Name fallback brand name: pramipexole dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Ingenus Pharmaceuticals, LLC	1d2b1d2c-ae22-424a-bad7-ce24a817b042	2025-04-24	Warnings, Adverse reactions	Name fallback brand name: Pramipexole dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	5e6f2187-a5cc-481e-b0a1-d38d3f92e822	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: Pramipexole dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	350a3f84-0f98-405f-bdae-6abbc47d48a4	2024-08-29	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	NorthStar RxLLC	946c8a72-8c48-4925-93d3-7940f4c0fd29	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride Extended-Release	PRAMIPEXOLE DIHYDROCHLORIDE	Vitruvias Therapeutics, Inc.	d07aad1b-e078-4fca-8386-ca2e8e899688	2024-07-23	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Macleods Pharmaceuticals Limited	1dbb8d2f-e0d9-4f8b-89d2-2a03496ef7be	2024-07-06	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Inc.	e18b67b6-a085-43e5-bb2b-fe74fa00cb65	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	A-S Medication Solutions	7cd6a546-d516-427c-af79-555390ccd35b	2023-12-15	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Limited	0a3ed933-ef5b-4091-8ae9-5768ae18514f	2023-12-08	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Limited	b6935240-ee81-49ef-adad-fb900d7f5127	2023-01-27	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Dr. Reddy's Laboratories Limited	00699692-532a-68fd-8a51-3770a81b2208	2021-08-31	Warnings, Adverse reactions	Name fallback brand name: Pramipexole dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride Extended-Release	PRAMIPEXOLE DIHYDROCHLORIDE	Xiamen LP Pharmaceutical Co., Ltd.	1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c	2021-06-16	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Limited	92f6ef1e-3256-45a7-a409-80dd85e95187	2017-11-20	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5248	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Sandoz Inc	ANDA	Current
0781-5249	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Sandoz Inc	ANDA	Current
0781-5250	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Sandoz Inc	ANDA	Current
0781-5251	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Sandoz Inc	ANDA	Current
0781-5252	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Sandoz Inc	ANDA	Current
0781-5281	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Sandoz Inc	ANDA	Current