Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079070
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE 2MG TABLET;ORAL Prescription AB No No
PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE 4MG TABLET;ORAL Prescription AB No No
PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE 8MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/10/2009 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079070s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/20/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

05/20/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

10/17/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

07/21/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

PERINDOPRIL ERBUMINE

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE 2MG TABLET;ORAL Prescription No AB 078138 ANI PHARMS INC
PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE 2MG TABLET;ORAL Prescription No AB 079070 AUROBINDO PHARMA
PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE 2MG TABLET;ORAL Prescription No AB 090072 HIKMA

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE 4MG TABLET;ORAL Prescription No AB 078138 ANI PHARMS INC
PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE 4MG TABLET;ORAL Prescription No AB 079070 AUROBINDO PHARMA
PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE 4MG TABLET;ORAL Prescription No AB 090072 HIKMA

TABLET;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE 8MG TABLET;ORAL Prescription No AB 078138 ANI PHARMS INC
PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE 8MG TABLET;ORAL Prescription No AB 079070 AUROBINDO PHARMA
PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE 8MG TABLET;ORAL Prescription No AB 090072 HIKMA

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