Application 020667

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.125MG	Yes	No
002	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.25MG	Yes	Yes
003	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	1MG	Yes	No
004	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	1.25MG	No	No
005	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	1.5MG	Yes	No
006	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.5MG	Yes	No
007	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.75MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020667-001	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01
N020667-002	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01
N020667-003	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01
N020667-004	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	1.25MG	TABLET / ORAL		1997-07-01
N020667-005	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01
N020667-006	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-02-12
N020667-007	MIRAPEX	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-07-30

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 8 · 294 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020667-001	MIRAPEX	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020667-002	MIRAPEX	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020667-003	MIRAPEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020667-004	MIRAPEX	1.25MG	TABLET / ORAL		1997-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020667-005	MIRAPEX	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020667-006	MIRAPEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020667-007	MIRAPEX	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020667-001	MIRAPEX	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020667-002	MIRAPEX	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020667-003	MIRAPEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020667-004	MIRAPEX	1.25MG	TABLET / ORAL		1997-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020667-005	MIRAPEX	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020667-006	MIRAPEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020667-007	MIRAPEX	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020667-001	MIRAPEX	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020667-002	MIRAPEX	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020667-003	MIRAPEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020667-004	MIRAPEX	1.25MG	TABLET / ORAL		1997-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020667-005	MIRAPEX	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020667-006	MIRAPEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020667-007	MIRAPEX	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020667-001	MIRAPEX	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020667-002	MIRAPEX	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020667-003	MIRAPEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020667-004	MIRAPEX	1.25MG	TABLET / ORAL		1997-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020667-005	MIRAPEX	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020667-006	MIRAPEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020667-007	MIRAPEX	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020667-001	MIRAPEX	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020667-002	MIRAPEX	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020667-003	MIRAPEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020667-004	MIRAPEX	1.25MG	TABLET / ORAL		1997-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020667-005	MIRAPEX	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020667-006	MIRAPEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1998-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020667-007	MIRAPEX	0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020667-001	MIRAPEX	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020667-002	MIRAPEX	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020667-003	MIRAPEX	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020667-004	MIRAPEX	1.25MG	TABLET / ORAL		1997-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020667-005	MIRAPEX	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1997-07-01	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	N020667-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020667-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020667-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020667-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020667-006	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020667-007	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020667-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020667-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020667-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020667-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020667-006	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020667-007	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020667-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020667-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020667-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020667-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020667-006	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020667-007	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020667-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020667-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020667-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020667-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020667-006	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020667-007	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020667-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020667-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020667-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020667-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020667-006	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020667-007	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020667-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020667-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020667-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020667-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020667-006	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020667-007	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020667-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020667-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020667-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020667-005	AB	1	`8869cabd3fbd…`

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	Bryant Ranch Prepack	468830df-941c-4363-b432-94de9b7fd2ac	2026-06-29	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	46f88017-7b0e-437e-90b1-37bdf9013e72	2026-05-22	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	7a5d1b22-179a-44ae-9545-2704414b9905	2026-05-15	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	f1ff3695-33db-471d-a3db-89fbb9ed9e0c	2026-05-14	Warnings, Adverse reactions	Name fallback 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 generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	422b27af-5e7d-4fe1-81bc-ed545c26b476	2026-04-17	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad	2026-04-07	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	bd0f7ae1-11ef-4fab-894f-c4c59f75aa99	2026-04-03	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	dd4b4e2a-97b5-417d-bb90-bec692dc359b	2026-04-02	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Torrent Pharmaceuticals Limited	60167d7c-469f-455a-a113-561841af5e59	2026-03-31	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	American Health Packaging	f4d97c2e-f447-4cfe-b9d4-852323f0cfb5	2026-03-03	Warnings, Adverse reactions	Name fallback 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 generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Major Pharmaceuticals	978c0e89-35f0-44a2-9302-8bed7e5d60e0	2026-01-21	Warnings, Adverse reactions	Name fallback 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 generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	ScieGen Pharmaceuticals Inc	395fee34-43dc-4840-a6b8-70d5736f9c8b	2025-12-24	Warnings, Adverse reactions	Name fallback 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 generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	794fdab8-1c15-4469-963e-4f9e3495536f	2025-11-17	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Inc.	4fe7106d-4bf6-4794-87cb-8df616994c41	2025-11-12	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Macleods Pharmaceuticals Limited	b8c94917-73a1-44c2-8fd8-07f45054176b	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	b978aa75-c62d-444b-9ec6-6c0d21a66688	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: PRAMIPEXOLE DIHYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0101	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0101	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0101	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0101	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0101	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0183	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0183	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0183	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0183	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0183	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0184	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0184	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0184	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0185	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0185	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0185	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0185	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0185	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0190	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0190	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0190	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0190	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0190	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0191	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0191	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0191	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0191	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
21695-867	Mirapex	pramipexole dihydrochloride	Rebel Distributors Corp	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68090	SUPPL	2021-07-14
68073	SUPPL	2021-07-14
65361	SUPPL	2020-11-30
62507	SUPPL	2020-04-08
62451	SUPPL	2020-04-06
61740	SUPPL	2020-01-30
54287	ORIG	2018-05-22
54193	SUPPL	2018-05-15
54142	SUPPL	2018-05-11
13176	SUPPL	2016-08-02
3046	SUPPL	2016-08-01
13175	SUPPL	2016-01-25
25482	SUPPL	2016-01-15
3045	SUPPL	2015-04-03
35118	SUPPL	2015-04-02
13174	SUPPL	2015-04-02
25481	SUPPL	2015-03-31
35117	SUPPL	2013-03-05
3044	SUPPL	2013-03-04
44065	ORIG	2012-09-19
35116	SUPPL	2012-09-06
25480	SUPPL	2012-09-05
13170	SUPPL	2012-07-30
35115	SUPPL	2012-07-19
35114	SUPPL	2012-07-19
13172	SUPPL	2012-07-19
13171	SUPPL	2012-07-19
25478	SUPPL	2012-07-18
25477	SUPPL	2012-07-18
3043	SUPPL	2012-07-18
3042	SUPPL	2012-07-18
3041	SUPPL	2012-07-18
25479	SUPPL	2011-05-16
13173	SUPPL	2011-05-16
35113	SUPPL	2009-01-06
25476	SUPPL	2009-01-06
13169	SUPPL	2009-01-06
12954	SUPPL	2009-01-06
3040	SUPPL	2009-01-06
3039	SUPPL	2009-01-06
20809	SUPPL	2007-06-12
25475	SUPPL	2006-11-14
25474	SUPPL	2006-11-14
35112	SUPPL	2006-11-09
12953	SUPPL	2006-11-09
25473	SUPPL	2003-05-30
41534	ORIG	1997-07-01
3038	ORIG	1997-07-01