Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204621
Company: ALVOGEN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEVIRAPINE NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
NEVIRAPINE NEVIRAPINE 100MG 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
09/11/2015 ORIG-2 Approval

Label is not available on this site.
07/10/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204621Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/14/2019 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
08/14/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

NEVIRAPINE

TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEVIRAPINE NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204621 ALVOGEN
NEVIRAPINE NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207698 AUROBINDO PHARMA LTD
NEVIRAPINE NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206448 CIPLA
NEVIRAPINE NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206879 MACLEODS PHARMS LTD
NEVIRAPINE NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205651 MYLAN
NEVIRAPINE NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203411 SANDOZ INC
VIRAMUNE XR NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 201152 BOEHRINGER INGELHEIM

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEVIRAPINE NEVIRAPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204621 ALVOGEN
NEVIRAPINE NEVIRAPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208616 AUROBINDO PHARMA LTD
VIRAMUNE XR NEVIRAPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 201152 BOEHRINGER INGELHEIM

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