Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201107
Company: HETERO LABS LTD III
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABACAVIR SULFATE ABACAVIR SULFATE EQ 20MG BASE/ML SOLUTION;ORAL Prescription AA 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
09/26/2016 ORIG-1 Approval Not Applicable Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201107Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201107s000TAltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/26/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201107Orig1s000lbl.pdf

ABACAVIR SULFATE

SOLUTION;ORAL; EQ 20MG BASE/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABACAVIR SULFATE ABACAVIR SULFATE EQ 20MG BASE/ML SOLUTION;ORAL Prescription No AA 201107 HETERO LABS LTD III
ZIAGEN ABACAVIR SULFATE EQ 20MG BASE/ML SOLUTION;ORAL Prescription Yes AA 020978 VIIV HLTHCARE

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