Last Updated: September 28, 2026

Details for New Drug Application (NDA): 078278

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NDA 078278 describes FAMCICLOVIR, which is a drug marketed by Apotex, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd V, Hikma, Macleods Pharms Ltd, Natco Pharma, and Teva Pharms, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the FAMCICLOVIR profile page.

The generic ingredient in FAMCICLOVIR is famciclovir. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the famciclovir profile page.

Summary for 078278

Tradename:	FAMCICLOVIR
Applicant:	Cipla
Ingredient:	famciclovir
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	125MG
Approval Date:	Mar 21, 2011	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Mar 21, 2011	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Mar 21, 2011	TE:		RLD:	No

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