MedPath
FDA Approval

Rasagiline

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
June 30, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Rasagiline(1 mg in 1 1)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Rasagiline

Product Details

NDC Product Code
0093-3061
Application Number
NDA021641
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
August 24, 2023
Code: LH8C2JI290Class: ACTIMQuantity: 1 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

Rasagiline

Product Details

NDC Product Code
0093-3060
Application Number
NDA021641
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
August 24, 2023
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
Code: LH8C2JI290Class: ACTIMQuantity: 0.5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
© Copyright 2025. All Rights Reserved by MedPath