Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078278
Company: CIPLA

Products on ANDA 078278

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FAMCICLOVIR	FAMCICLOVIR	125MG	TABLET;ORAL	Discontinued	None	No	No
FAMCICLOVIR	FAMCICLOVIR	250MG	TABLET;ORAL	Discontinued	None	No	No
FAMCICLOVIR	FAMCICLOVIR	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078278

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/21/2011	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
07/08/2019	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/08/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/30/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/13/2011	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.