Azilect
These highlights do not include all the information needed to use AZILECT® safely and effectively. See full prescribing information for AZILECT®. AZILECT® (rasagiline mesylate) Tablets for Oral Use Initial U.S. Approval: 2006
Approved
Approval ID
eb558270-1b12-4704-9b09-39f668f30529
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
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 Code54868-6206
Application NumberNDA021641
Product Classification
M
Marketing Category
C73594
G
Generic Name
rasagiline mesylate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2010
FDA Product Classification
INGREDIENTS (5)
RASAGILINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: LH8C2JI290
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT