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Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077487

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NDA 077487 describes FAMCICLOVIR, which is a drug marketed by Aurobindo Pharma Ltd, Macleods Pharms Ltd, West-ward Pharms Int, Mylan, Hetero Labs Ltd V, Cipla Ltd, Apotex, and Teva Pharms, and is included in eight NDAs. It is available from eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the famciclovir profile page.

Summary for NDA: 077487

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 077487

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 077487

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMCICLOVIR
famciclovir
TABLET;ORAL 077487 ANDA Teva Pharmaceuticals USA, Inc. 0093-8117 0093-8117-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-8117-56)
FAMCICLOVIR
famciclovir
TABLET;ORAL 077487 ANDA Teva Pharmaceuticals USA, Inc. 0093-8118 0093-8118-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-8118-56)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Aug 24, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Aug 24, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Aug 24, 2007TE:ABRLD:No


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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. thinkBiotech performs no independent verifification 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.

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