Drugs@FDA: FDA Approved Drug Products

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

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 MALTA
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 PHARMS INC
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 MALTA
NEVIRAPINE NEVIRAPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208616 AUROBINDO PHARMA LTD
NEVIRAPINE NEVIRAPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206271 MYLAN PHARMS INC
VIRAMUNE XR NEVIRAPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 201152 BOEHRINGER INGELHEIM

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