Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078064
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EFAVIRENZ EFAVIRENZ 50MG CAPSULE;ORAL Prescription AB No No
EFAVIRENZ EFAVIRENZ 100MG CAPSULE;ORAL Prescription None No No
EFAVIRENZ EFAVIRENZ 200MG CAPSULE;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
12/15/2017 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/078064Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/04/2020 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

EFAVIRENZ

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFAVIRENZ EFAVIRENZ 50MG CAPSULE;ORAL Prescription No AB 078064 AUROBINDO PHARMA LTD
SUSTIVA EFAVIRENZ 50MG CAPSULE;ORAL Prescription Yes AB 020972 BRISTOL MYERS SQUIBB

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFAVIRENZ EFAVIRENZ 200MG CAPSULE;ORAL Prescription No AB 078064 AUROBINDO PHARMA LTD
SUSTIVA EFAVIRENZ 200MG CAPSULE;ORAL Prescription Yes AB 020972 BRISTOL MYERS SQUIBB

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