Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091471
Company: MYLAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EFAVIRENZ EFAVIRENZ 600MG 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
02/17/2016 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/091471Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091471Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/17/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/091471Orig1s000lbl.pdf

EFAVIRENZ

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFAVIRENZ EFAVIRENZ 600MG TABLET;ORAL Prescription No AB 077673 AUROBINDO PHARMA LTD
EFAVIRENZ EFAVIRENZ 600MG TABLET;ORAL Prescription No AB 205322 AUROBINDO PHARMA LTD
EFAVIRENZ EFAVIRENZ 600MG TABLET;ORAL Prescription No AB 204766 CIPLA
EFAVIRENZ EFAVIRENZ 600MG TABLET;ORAL Prescription No AB 078886 HETERO LABS LTD III
EFAVIRENZ EFAVIRENZ 600MG TABLET;ORAL Prescription No AB 091471 MYLAN
EFAVIRENZ EFAVIRENZ 600MG TABLET;ORAL Prescription No AB 204869 STRIDES PHARMA
SUSTIVA EFAVIRENZ 600MG TABLET;ORAL Prescription Yes AB 021360 BRISTOL MYERS SQUIBB

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