Last Updated: August 9, 2026

Details for New Drug Application (NDA): 091480

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NDA 091480 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 are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the famciclovir profile page.

Summary for 091480

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	125MG
Approval Date:	Jul 22, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jul 22, 2011	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jul 22, 2011	TE:	AB	RLD:	No

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