FDA.reportPublic FDA data

Application 022514

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDETABLET, EXTENDED RELEASE; ORAL0.375MGNoNo
002MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDETABLET, EXTENDED RELEASE; ORAL0.75MGNoNo
003MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDETABLET, EXTENDED RELEASE; ORAL1.5MGNoNo
004MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDETABLET, EXTENDED RELEASE; ORAL3MGNoNo
005MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDETABLET, EXTENDED RELEASE; ORAL4.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack468830df-941c-4363-b432-94de9b7fd2ac2026-06-29Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack46f88017-7b0e-437e-90b1-37bdf9013e722026-05-22Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack7a5d1b22-179a-44ae-9545-2704414b99052026-05-15Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepackf1ff3695-33db-471d-a3db-89fbb9ed9e0c2026-05-14Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEA-S Medication Solutions3db0613d-524b-4b33-9a07-602f84d6c3042026-04-26Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack422b27af-5e7d-4fe1-81bc-ed545c26b4762026-04-17Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad2026-04-07Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepackbd0f7ae1-11ef-4fab-894f-c4c59f75aa992026-04-03Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepackdd4b4e2a-97b5-417d-bb90-bec692dc359b2026-04-02Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDETorrent Pharmaceuticals Limited60167d7c-469f-455a-a113-561841af5e592026-03-31Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEAmerican Health Packagingf4d97c2e-f447-4cfe-b9d4-852323f0cfb52026-03-03Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEGolden State Medical Supply, Inc.f8ac759f-59fb-49e4-a772-4114facdaea32026-01-26Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEMajor Pharmaceuticals978c0e89-35f0-44a2-9302-8bed7e5d60e02026-01-21Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA44c336d2-01d1-4f13-bad9-549cdc3505ec2025-12-30Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEScieGen Pharmaceuticals Inc395fee34-43dc-4840-a6b8-70d5736f9c8b2025-12-24Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDERising Pharma Holdings, Inc.56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec2025-12-11Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEBryant Ranch Prepack794fdab8-1c15-4469-963e-4f9e3495536f2025-11-17Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEAlembic Pharmaceuticals Inc.4fe7106d-4bf6-4794-87cb-8df616994c412025-11-12Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEMacleods Pharmaceuticals Limitedb8c94917-73a1-44c2-8fd8-07f45054176b2025-10-15Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.b978aa75-c62d-444b-9ec6-6c0d21a666882025-10-14Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44187ORIG2012-09-19
44767ORIG2010-09-03
42545ORIG2010-09-03
38800ORIG2010-03-26
7488ORIG2010-03-24