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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204990
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;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
03/28/2017 ORIG-1 Approval STANDARD Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204990Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204990Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/24/2020 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

02/24/2020 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/24/2020 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

ABACAVIR SULFATE AND LAMIVUDINE

TABLET;ORAL; EQ 600MG BASE;300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET;ORAL Prescription No AB 090159 AUROBINDO PHARMA LTD
ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET;ORAL Prescription No AB 091144 CIPLA
ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET;ORAL Prescription No AB 216332 LAURUS
ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET;ORAL Prescription No AB 204990 LUPIN LTD
ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET;ORAL Prescription No AB 079246 TEVA PHARMS USA
EPZICOM ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET;ORAL Prescription Yes AB 021652 VIIV HLTHCARE
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