Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077487
Company: TEVA PHARMS
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 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
08/24/2007 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077487s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077487s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/08/2019 SUPPL-9 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

06/27/2013 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

07/29/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/09/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

04/29/2009 SUPPL-3 Labeling

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 078278 CIPLA
FAMCICLOVIR FAMCICLOVIR 125MG TABLET;ORAL Prescription No AB 202438 HETERO LABS LTD V
FAMCICLOVIR FAMCICLOVIR 125MG TABLET;ORAL Prescription No AB 090128 HIKMA
FAMCICLOVIR FAMCICLOVIR 125MG TABLET;ORAL Prescription No AB 201022 MACLEODS PHARMS LTD
FAMCICLOVIR FAMCICLOVIR 125MG TABLET;ORAL Prescription No AB 201333 MYLAN
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 078278 CIPLA
FAMCICLOVIR FAMCICLOVIR 250MG TABLET;ORAL Prescription No AB 202438 HETERO LABS LTD V
FAMCICLOVIR FAMCICLOVIR 250MG TABLET;ORAL Prescription No AB 090128 HIKMA
FAMCICLOVIR FAMCICLOVIR 250MG TABLET;ORAL Prescription No AB 201022 MACLEODS PHARMS LTD
FAMCICLOVIR FAMCICLOVIR 250MG TABLET;ORAL Prescription No AB 201333 MYLAN
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 078278 CIPLA
FAMCICLOVIR FAMCICLOVIR 500MG TABLET;ORAL Prescription No AB 202438 HETERO LABS LTD V
FAMCICLOVIR FAMCICLOVIR 500MG TABLET;ORAL Prescription No AB 090128 HIKMA
FAMCICLOVIR FAMCICLOVIR 500MG TABLET;ORAL Prescription No AB 201022 MACLEODS PHARMS LTD
FAMCICLOVIR FAMCICLOVIR 500MG TABLET;ORAL Prescription No AB 201333 MYLAN
FAMCICLOVIR FAMCICLOVIR 500MG TABLET;ORAL Prescription No AB 077487 TEVA PHARMS

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