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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078584
Company: HETERO LABS LTD III
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEVIRAPINE NEVIRAPINE 200MG 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
05/22/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078584taltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/24/2020 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

06/24/2020 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

03/20/2013 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

09/14/2012 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

NEVIRAPINE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEVIRAPINE NEVIRAPINE 200MG TABLET;ORAL Prescription No AB 077521 AUROBINDO
NEVIRAPINE NEVIRAPINE 200MG TABLET;ORAL Prescription No AB 077956 CIPLA
NEVIRAPINE NEVIRAPINE 200MG TABLET;ORAL Prescription No AB 078584 HETERO LABS LTD III
NEVIRAPINE NEVIRAPINE 200MG TABLET;ORAL Prescription No AB 090688 MACLEODS PHARMS LTD
NEVIRAPINE NEVIRAPINE 200MG TABLET;ORAL Prescription No AB 203080 MICRO LABS LTD
NEVIRAPINE NEVIRAPINE 200MG TABLET;ORAL Prescription No AB 202523 MYLAN PHARMS INC
NEVIRAPINE NEVIRAPINE 200MG TABLET;ORAL Prescription No AB 078195 STRIDES PHARMA
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