You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 17, 2025

Details for New Drug Application (NDA): 091114

✉ Email this page to a colleague

« Back to Dashboard

NDA 091114 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 ten 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. Ten suppliers are listed for this compound. Additional details are available on the famciclovir profile page.

Summary for 091114

Tradename:	FAMCICLOVIR
Applicant:	Aurobindo Pharma Ltd
Ingredient:	famciclovir
Patents:	0

Pharmacology for NDA: 091114

Mechanism of Action	DNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 091114

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FAMCICLOVIR	famciclovir	TABLET;ORAL	091114	ANDA	Rising Pharma Holdings, Inc.	64980-349	64980-349-03	30 TABLET, FILM COATED in 1 BOTTLE (64980-349-03)
FAMCICLOVIR	famciclovir	TABLET;ORAL	091114	ANDA	Rising Pharma Holdings, Inc.	64980-350	64980-350-03	30 TABLET, FILM COATED in 1 BOTTLE (64980-350-03)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.