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Drugs@FDA: FDA-Approved Drugs

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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
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/06/2022 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/22/2020 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

12/22/2020 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/22/2020 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/22/2020 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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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