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#

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pramipexole DihydrochloridePRAMIPEXOLE DIHYDROCHLORIDEA-S Medication Solutions29b639e3-25a5-4c2f-b4ea-a119db79fe0c2026-09-09Warnings, Adverse reactionsName fallback
generic name: PRAMIPEXOLE DIHYDROCHLORIDE
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

Reported adverse events (FAERS/openFDA)#

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

Documents#

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