MedPath
FDA Product

Famciclovir

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Famciclovir

71205-609

Regulatory Information

71205-609

ANDA201022

C73584

January 1, 2023

USA

These highlights do not include all the information needed to use  FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR  TABLETS. FAMCICLOVIR tablets, for oral use Initial U.S. Approval: 1994

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

Proficient Rx LP

079196022

Active Ingredients

FAMCICLOVIR

Quantity: 500 mg in 1 1

Code: QIC03ANI02

Class Code: ACTIB

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 2165RE0K14

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

LACTOSE, UNSPECIFIED FORM

Code: J2B2A4N98G

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

PENCICLOVIR

Code: 359HUE8FJC

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