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FDA Product

Rasagiline

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

Basic Information

Rasagiline

47781-690

Regulatory Information

47781-690

ANDA201970

C73584

March 27, 2019

USA

These highlights do not include all the information needed to use RASAGILINE TABLETS safely and effectively. See full prescribing information for RASAGILINE TABLETS. RASAGILINE tablets, for oral use Initial U.S. Approval: 2006

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

Alvogen, Inc.

008057330

Active Ingredients

Rasagiline Mesylate

Quantity: 1 mg in 1 1

Code: LH8C2JI290

Class Code: ACTIM

Inactive Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

CITRIC ACID MONOHYDRATE

Code: 2968PHW8QP

Class Code: IACT

Active Moieties

Rasagiline

Code: 003N66TS6T

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