Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077844
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE 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
12/17/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077844s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/25/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/25/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/25/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

ABACAVIR SULFATE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 201570 APOTEX INC
ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 077844 AUROBINDO PHARMA LTD
ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 091560 HETERO LABS LTD III
ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 091294 MYLAN PHARMS INC
ABACAVIR SULFATE ABACAVIR SULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 091050 STRIDES PHARMA
ZIAGEN ABACAVIR SULFATE EQ 300MG BASE TABLET;ORAL Prescription Yes AB 020977 VIIV HLTHCARE

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