Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201576
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;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
06/06/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/19/2015 SUPPL-1 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

ROPINIROLE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022008 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090869 ACTAVIS ELIZABETH
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202786 ALEMBIC PHARMS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201576 DR REDDYS LABS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200431 WATSON LABS INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091395 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022008 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090869 ACTAVIS ELIZABETH
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202786 ALEMBIC PHARMS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201576 DR REDDYS LABS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200431 WATSON LABS INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091395 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; EQ 6MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022008 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090869 ACTAVIS ELIZABETH
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202786 ALEMBIC PHARMS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201576 DR REDDYS LABS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200431 WATSON LABS INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091395 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; EQ 8MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022008 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090869 ACTAVIS ELIZABETH
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202786 ALEMBIC PHARMS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201576 DR REDDYS LABS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200431 WATSON LABS INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091395 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; EQ 12MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REQUIP XL ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022008 GLAXOSMITHKLINE LLC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090869 ACTAVIS ELIZABETH
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202786 ALEMBIC PHARMS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201576 DR REDDYS LABS LTD
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200431 WATSON LABS INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091395 WOCKHARDT LTD

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