Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204022
Company: ACCORD HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET;ORAL Prescription AB No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription AB No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription AB No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription AB No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET;ORAL Prescription AB No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription AB No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/28/2017 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/26/2020 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
08/26/2020 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

ROPINIROLE HYDROCHLORIDE

TABLET;ORAL; EQ 0.25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET;ORAL Prescription Yes AB 020658 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET;ORAL Prescription No AB 204022 ACCORD HLTHCARE
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET;ORAL Prescription No AB 090429 ALEMBIC LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET;ORAL Prescription No AB 090411 CADILA
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET;ORAL Prescription No AB 079050 CELLTRION
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET;ORAL Prescription No AB 090135 GLENMARK GENERICS
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET;ORAL Prescription No AB 079165 MLV
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET;ORAL Prescription No AB 078881 MYLAN
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET;ORAL Prescription No AB 079229 ORCHID HLTHCARE
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET;ORAL Prescription No AB 078110 PRINSTON INC

TABLET;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription Yes AB 020658 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 204022 ACCORD HLTHCARE
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 090429 ALEMBIC LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 090411 CADILA
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 079050 CELLTRION
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 090135 GLENMARK GENERICS
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 079165 MLV
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 078881 MYLAN
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 079229 ORCHID HLTHCARE
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 078110 PRINSTON INC

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription Yes AB 020658 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 204022 ACCORD HLTHCARE
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 090429 ALEMBIC LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 090411 CADILA
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 079050 CELLTRION
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 090135 GLENMARK GENERICS
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 079165 MLV
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 078881 MYLAN
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 079229 ORCHID HLTHCARE
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 078110 PRINSTON INC

TABLET;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription Yes AB 020658 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 204022 ACCORD HLTHCARE
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 090429 ALEMBIC LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 090411 CADILA
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 079050 CELLTRION
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 090135 GLENMARK GENERICS
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 079165 MLV
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 078881 MYLAN
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 079229 ORCHID HLTHCARE
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET;ORAL Prescription No AB 078110 PRINSTON INC

TABLET;ORAL; EQ 3MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET;ORAL Prescription Yes AB 020658 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET;ORAL Prescription No AB 204022 ACCORD HLTHCARE
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET;ORAL Prescription No AB 090429 ALEMBIC LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET;ORAL Prescription No AB 090411 CADILA
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET;ORAL Prescription No AB 079050 CELLTRION
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET;ORAL Prescription No AB 090135 GLENMARK GENERICS
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET;ORAL Prescription No AB 079165 MLV
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET;ORAL Prescription No AB 078881 MYLAN
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET;ORAL Prescription No AB 079229 ORCHID HLTHCARE
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET;ORAL Prescription No AB 078110 PRINSTON INC

TABLET;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription Yes AB 020658 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 204022 ACCORD HLTHCARE
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 090429 ALEMBIC LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 090411 CADILA
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 079050 CELLTRION
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 090135 GLENMARK GENERICS
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 079165 MLV
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 078881 MYLAN
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 079229 ORCHID HLTHCARE
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Prescription No AB 078110 PRINSTON INC

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription Yes AB 020658 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 204022 ACCORD HLTHCARE
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 090429 ALEMBIC LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 090411 CADILA
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 079050 CELLTRION
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 090135 GLENMARK GENERICS
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 079165 MLV
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 078881 MYLAN
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 079229 ORCHID HLTHCARE
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 078110 PRINSTON INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English