Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079246
Company: TEVA PHARMS USA
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
09/29/2016 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/079246s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079246Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/29/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/079246s000lbl.pdf

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 206151 AUROBINDO PHARMA LTD
ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET;ORAL Prescription No AB 091144 CIPLA LTD
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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