Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202912
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE EQ 300MG BASE;150MG;300MG 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
12/05/2013 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202912Orig1s000ltr.pdf

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE

TABLET;ORAL; EQ 300MG BASE;150MG;300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE EQ 300MG BASE;150MG;300MG TABLET;ORAL Prescription No AB 202912 LUPIN LTD
TRIZIVIR ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE EQ 300MG BASE;150MG;300MG TABLET;ORAL Prescription Yes AB 021205 VIIV HLTHCARE

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