Rasagiline mesylate
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
Approved
Approval ID
7d070521-ea04-4483-bdb9-54a8859700df
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2023
Manufacturers
FDA
Avet Pharmaceuticals Inc.
DUNS: 780779901
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rasagiline mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-747
Application NumberANDA206153
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rasagiline mesylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2023
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
RASAGILINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: LH8C2JI290
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
Rasagiline mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-746
Application NumberANDA206153
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rasagiline mesylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2023
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
RASAGILINE MESYLATEActive
Quantity: 0.5 mg in 1 1
Code: LH8C2JI290
Classification: ACTIM
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT