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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201022
Company: MACLEODS PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FAMCICLOVIR FAMCICLOVIR 125MG TABLET;ORAL Prescription AB No No
FAMCICLOVIR FAMCICLOVIR 250MG TABLET;ORAL Prescription AB No No
FAMCICLOVIR FAMCICLOVIR 500MG 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
01/12/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2019 SUPPL-22 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

07/25/2019 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

11/19/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

05/30/2013 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/30/2013 SUPPL-1 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

FAMCICLOVIR

TABLET;ORAL; 125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FAMCICLOVIR FAMCICLOVIR 125MG TABLET;ORAL Prescription No AB 091480 APOTEX
FAMCICLOVIR FAMCICLOVIR 125MG TABLET;ORAL Prescription No AB 091114 AUROBINDO PHARMA LTD
FAMCICLOVIR FAMCICLOVIR 125MG TABLET;ORAL Prescription No AB 202438 HETERO LABS LTD V
FAMCICLOVIR FAMCICLOVIR 125MG TABLET;ORAL Prescription No AB 201022 MACLEODS PHARMS LTD
FAMCICLOVIR FAMCICLOVIR 125MG TABLET;ORAL Prescription No AB 077487 TEVA PHARMS

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FAMCICLOVIR FAMCICLOVIR 250MG TABLET;ORAL Prescription No AB 091480 APOTEX
FAMCICLOVIR FAMCICLOVIR 250MG TABLET;ORAL Prescription No AB 091114 AUROBINDO PHARMA LTD
FAMCICLOVIR FAMCICLOVIR 250MG TABLET;ORAL Prescription No AB 202438 HETERO LABS LTD V
FAMCICLOVIR FAMCICLOVIR 250MG TABLET;ORAL Prescription No AB 201022 MACLEODS PHARMS LTD
FAMCICLOVIR FAMCICLOVIR 250MG TABLET;ORAL Prescription No AB 077487 TEVA PHARMS

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FAMCICLOVIR FAMCICLOVIR 500MG TABLET;ORAL Prescription No AB 091480 APOTEX
FAMCICLOVIR FAMCICLOVIR 500MG TABLET;ORAL Prescription No AB 091114 AUROBINDO PHARMA LTD
FAMCICLOVIR FAMCICLOVIR 500MG TABLET;ORAL Prescription No AB 202438 HETERO LABS LTD V
FAMCICLOVIR FAMCICLOVIR 500MG TABLET;ORAL Prescription No AB 201022 MACLEODS PHARMS LTD
FAMCICLOVIR FAMCICLOVIR 500MG TABLET;ORAL Prescription No AB 077487 TEVA PHARMS
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