Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211306
Company: ANNORA
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
03/21/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

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 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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