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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091480
Company: APOTEX

Products on ANDA 091480

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091480

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/22/2011	ORIG-1	Approval				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-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/25/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/04/2016	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091480

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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