Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Novitium Pharma LLC
Novitium Pharma LLC
080301870
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
70954-504Application Number
ANDA075352Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 13, 2021LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SelegilineActive
Code: 6W731X367QClass: ACTIBQuantity: 5 mg in 1 1
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SHELLACInactive
Code: MB5IUD6JUAClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT