MedPath
FDA Product

Zafirlukast

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

Basic Information

Zafirlukast

55111-625

Regulatory Information

55111-625

ANDA090372

C73584

December 20, 2016

USA

ZAFIRLUKASTTABLETS

HUMAN PRESCRIPTION DRUG LABEL

9

Company Information

650562841

Active Ingredients

hydroxypropyl cellulose

Code: RFW2ET671P

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

Zafirlukast

Quantity: 10 mg in 1 1

Code: XZ629S5L50

Class Code: ACTIB

lactose monohydrate

Code: EWQ57Q8I5X

Class Code: IACT

magnesium stearate

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

polyethylene glycol 400

Code: B697894SGQ

Class Code: IACT

titanium dioxide

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

Zafirlukast

Code: XZ629S5L50

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