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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202941
Company: APOTEX

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMIVUDINE LAMIVUDINE 100MG 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
01/02/2014 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202941Orig1s000_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202941Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/05/2023 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
01/26/2021 SUPPL-4 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
01/26/2021 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
01/26/2021 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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/2014/202941Orig1s000_lbl.pdf

LAMIVUDINE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMIVUDINE LAMIVUDINE 100MG TABLET;ORAL Prescription No AB 211306 ANNORA
LAMIVUDINE LAMIVUDINE 100MG TABLET;ORAL Prescription No AB 202941 APOTEX
LAMIVUDINE LAMIVUDINE 100MG TABLET;ORAL Prescription No AB 203260 HETERO LABS LTD V
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