MedPath
FDA Approval

Rasagiline

September 30, 2022

Human Prescription Drug Label

Rasagiline(0.5 mg in 1 1)

Manufacturing Establishments (1)

Alkem Laboratories Limited

Ascend Laboratories, LLC

915628612

Products (2)

Rasagiline

67877-259

ANDA201889

ANDA (C73584)

ORAL

November 30, 2021

Code: LH8C2JI290Class: ACTIMQuantity: 0.5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT

Rasagiline

67877-260

ANDA201889

ANDA (C73584)

ORAL

November 30, 2021

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: LH8C2JI290Class: ACTIMQuantity: 1 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
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