Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203260
Company: HETERO LABS LTD V
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMIVUDINE LAMIVUDINE 100MG 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
01/02/2014 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203260Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203260Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/02/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203260Orig1s000lbl.pdf

LAMIVUDINE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPIVIR-HBV LAMIVUDINE 100MG TABLET;ORAL Prescription Yes AB 021003 GLAXOSMITHKLINE
LAMIVUDINE LAMIVUDINE 100MG TABLET;ORAL Prescription No AB 202941 APOTEX INC
LAMIVUDINE LAMIVUDINE 100MG TABLET;ORAL Prescription No AB 203260 HETERO LABS LTD V
LAMIVUDINE LAMIVUDINE 100MG TABLET;ORAL Prescription No AB 204002 MYLAN PHARMS INC

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