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Details for New Drug Application (NDA): 091114

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NDA 091114 describes FAMCICLOVIR, which is a drug marketed by Aurobindo Pharma Ltd, Macleods Pharms Ltd, Roxane, Mylan, Hetero Labs Ltd V, Cipla Ltd, Apotex, and Teva Pharms, and is included in eight NDAs. It is available from seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the famciclovir profile page.

Summary for NDA: 091114

Aurobindo Pharma Ltd
Therapeutic Class:Antivirals

Pharmacology for NDA: 091114

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 091114

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 091114 ANDA NorthStar Rx LLC 16714-300 16714-300-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-300-01)
TABLET;ORAL 091114 ANDA NorthStar Rx LLC 16714-304 16714-304-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-304-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Mar 21, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Mar 21, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 21, 2011TE:ABRLD:No

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