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 44.

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 2 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090190-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090190-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090190-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090190-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	2010-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090190-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090190-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-07-06	`79d66fd596c7…`

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	A-S Medication Solutions	29b639e3-25a5-4c2f-b4ea-a119db79fe0c	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	468830df-941c-4363-b432-94de9b7fd2ac	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	46f88017-7b0e-437e-90b1-37bdf9013e72	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	7a5d1b22-179a-44ae-9545-2704414b9905	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	f1ff3695-33db-471d-a3db-89fbb9ed9e0c	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	A-S Medication Solutions	3db0613d-524b-4b33-9a07-602f84d6c304	2026-04-26	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	422b27af-5e7d-4fe1-81bc-ed545c26b476	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	bd0f7ae1-11ef-4fab-894f-c4c59f75aa99	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	dd4b4e2a-97b5-417d-bb90-bec692dc359b	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Torrent Pharmaceuticals Limited	60167d7c-469f-455a-a113-561841af5e59	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	American Health Packaging	f4d97c2e-f447-4cfe-b9d4-852323f0cfb5	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Golden State Medical Supply, Inc.	f8ac759f-59fb-49e4-a772-4114facdaea3	2026-01-26	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Major Pharmaceuticals	978c0e89-35f0-44a2-9302-8bed7e5d60e0	2026-01-21	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	44c336d2-01d1-4f13-bad9-549cdc3505ec	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Pramipexole dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	ScieGen Pharmaceuticals Inc	395fee34-43dc-4840-a6b8-70d5736f9c8b	2025-12-24	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Rising Pharma Holdings, Inc.	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	794fdab8-1c15-4469-963e-4f9e3495536f	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Inc.	4fe7106d-4bf6-4794-87cb-8df616994c41	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Macleods Pharmaceuticals Limited	b8c94917-73a1-44c2-8fd8-07f45054176b	2025-10-15	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