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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078881
Company: MYLAN
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
05/05/2008 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
12/07/2020 SUPPL-22 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

03/03/2020 SUPPL-20 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

03/03/2020 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

10/19/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

02/22/2012 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/30/2009 SUPPL-4 Labeling-Patient Package Insert

Label is not available on this site.

05/19/2008 SUPPL-1 Labeling

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
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 ORBION PHARMS
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
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 ORBION PHARMS
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
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 ORBION PHARMS
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
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 ORBION PHARMS
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
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 ORBION PHARMS
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
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 ORBION PHARMS
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
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 ORBION PHARMS
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 078110 PRINSTON INC
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