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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091144
Company: CIPLA
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 Yes
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 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091144s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2023 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/07/2023 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/25/2019 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/25/2019 SUPPL-13 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
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