Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077702
Company: AUROBINDO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEVIRAPINE NEVIRAPINE 50MG/5ML SUSPENSION;ORAL Prescription AA 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
05/22/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077702TA.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/21/2019 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

08/21/2019 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/16/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

02/04/2013 SUPPL-7 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

NEVIRAPINE

SUSPENSION;ORAL; 50MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEVIRAPINE NEVIRAPINE 50MG/5ML SUSPENSION;ORAL Prescription No AA 077702 AUROBINDO
NEVIRAPINE NEVIRAPINE 50MG/5ML SUSPENSION;ORAL Prescription No AA 207684 CIPLA
VIRAMUNE NEVIRAPINE 50MG/5ML SUSPENSION;ORAL Prescription Yes AA 020933 BOEHRINGER INGELHEIM

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