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Abbreviated New Drug Application (ANDA): 090869
Company: ACTAVIS ELIZABETH
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
05/17/2012 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090869Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/28/2015 SUPPL-11 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
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 091395 CELLTRION
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 204413 PRINSTON INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC

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
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 091395 CELLTRION
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 204413 PRINSTON INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC

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
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 091395 CELLTRION
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 204413 PRINSTON INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 6MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC

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
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 091395 CELLTRION
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 204413 PRINSTON INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC

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
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 091395 CELLTRION
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 204413 PRINSTON INC
ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 12MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201047 SANDOZ INC
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