MedPath
FDA Product

LETROZOLE

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

Basic Information

LETROZOLE

24724-030

Regulatory Information

24724-030

ANDA201804

C73584

June 15, 2011

USA

These highlights do not include all the information needed to use letrozole tablets safely and effectively. See full prescribing information for letrozole tablets. letrozole tablets USP ,2.5 mg Initial U.S. Approval: 1997

Human Prescription Drug Label

3

Company Information

INDICUS PHARMA LLC

793870606

Active Ingredients

LETROZOLE

Quantity: 2.5 mg in 1 1

Code: 7LKK855W8I

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

Active Moieties

LETROZOLE

Code: 7LKK855W8I

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