Application 022421

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.375MG	Yes	Yes
002	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.75MG	Yes	No
003	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1.5MG	Yes	No
004	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	3MG	Yes	No
005	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	4.5MG	Yes	No
006	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	2.25MG	Yes	No
007	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	3.75MG	Yes	No

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

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
N022421-001	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19
N022421-002	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19
N022421-003	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19
N022421-004	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19
N022421-005	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19
N022421-006	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17
N022421-007	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022421-001	7695734	2028-04-26		Drug product
N022421-001	8679533	2029-09-08	U-219	Drug product	2014-03-25
N022421-002	7695734	2028-04-26		Drug product
N022421-002	8679533	2029-09-08	U-219	Drug product	2014-03-25
N022421-003	7695734	2028-04-26		Drug product
N022421-003	8679533	2029-09-08	U-219	Drug product	2014-03-25
N022421-004	7695734	2028-04-26		Drug product
N022421-004	8679533	2029-09-08	U-219	Drug product	2014-03-25
N022421-005	7695734	2028-04-26		Drug product
N022421-005	8679533	2029-09-08	U-219	Drug product	2014-03-25
N022421-006	7695734	2028-04-26		Drug product	2011-06-30
N022421-006	8679533	2029-09-08	U-219	Drug product	2014-03-25
N022421-007	7695734	2028-04-26		Drug product	2011-06-30
N022421-007	8679533	2029-09-08	U-219	Drug product	2014-03-25

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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N022421-001	MIRAPEX ER	0.375MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-002	MIRAPEX ER	0.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-003	MIRAPEX ER	1.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-004	MIRAPEX ER	3MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-005	MIRAPEX ER	4.5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-02-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-006	MIRAPEX ER	2.25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-007	MIRAPEX ER	3.75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-06-17	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N022421-001	7695734	2028-04-26		Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-001	8679533	2029-09-08	U-219	Drug product	2014-03-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-002	7695734	2028-04-26		Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-002	8679533	2029-09-08	U-219	Drug product	2014-03-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-003	7695734	2028-04-26		Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-003	8679533	2029-09-08	U-219	Drug product	2014-03-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-004	7695734	2028-04-26		Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-004	8679533	2029-09-08	U-219	Drug product	2014-03-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-005	7695734	2028-04-26		Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-005	8679533	2029-09-08	U-219	Drug product	2014-03-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-006	7695734	2028-04-26		Drug product	2011-06-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-006	8679533	2029-09-08	U-219	Drug product	2014-03-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-007	7695734	2028-04-26		Drug product	2011-06-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022421-007	8679533	2029-09-08	U-219	Drug product	2014-03-25	`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 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 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0109	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0109	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0109	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0109	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0109	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0113	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0113	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0113	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0113	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0113	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0115	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0115	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0115	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0115	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0115	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0116	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0116	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0116	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0116	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0116	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0285	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0285	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0285	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0285	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0285	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0286	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0286	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0286	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0286	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0286	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0287	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0287	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0287	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0287	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0287	Mirapex	pramipexole dihydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78753	SUPPL	2024-07-02
78776	SUPPL	2024-06-12
68087	SUPPL	2021-07-14
68078	SUPPL	2021-07-14
64193	SUPPL	2020-08-04
61741	SUPPL	2020-01-30
54194	SUPPL	2018-05-15
54141	SUPPL	2018-05-11
38690	SUPPL	2016-08-02
7368	SUPPL	2016-08-01
17569	SUPPL	2016-01-15
7367	SUPPL	2016-01-15
38689	SUPPL	2015-04-02
7366	SUPPL	2015-04-01
17567	SUPPL	2014-05-12
29708	SUPPL	2014-05-09
38688	SUPPL	2013-03-05
29709	SUPPL	2013-03-04
44184	ORIG	2012-09-19
17568	SUPPL	2012-09-06
7365	SUPPL	2012-09-05
42519	ORIG	2010-08-20
24303	ORIG	2010-08-20
38687	SUPPL	2010-07-22
7364	SUPPL	2010-07-15
7363	ORIG	2010-02-26
38686	ORIG	2010-02-25