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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 201022


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NDA 201022 describes FAMCICLOVIR, which is a drug marketed by Apotex, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd V, Hikma, Macleods Pharms Ltd, Mylan, 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 201022
Tradename:FAMCICLOVIR
Applicant:Macleods Pharms Ltd
Ingredient:famciclovir
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201022
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 201022
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMCICLOVIR famciclovir TABLET;ORAL 201022 ANDA Macleods Pharmaceuticals Limited 33342-024 33342-024-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-024-07)
FAMCICLOVIR famciclovir TABLET;ORAL 201022 ANDA Macleods Pharmaceuticals Limited 33342-025 33342-025-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-025-07)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Jan 12, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jan 12, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jan 12, 2012TE:ABRLD:No

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