Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Apotex Inc.
205576023
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Apotex Inc.
Apotex Corp.
Apotex Inc.
209429182
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SELEGILINE HYDROCHLORIDE
Product Details
NDC Product Code
60505-0055Application Number
ANDA075321Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 15, 2023TALCInactive
Code: 7SEV7J4R1UClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SelegilineActive
Code: 6W731X367QClass: ACTIBQuantity: 5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT