Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Catalent Pharma Solutions Limited
Bausch Health US, LLC
237676320
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ZELAPAR
Product Details
NDC Product Code
0187-0453Application Number
NDA021479Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
June 1, 2021SelegilineActive
Code: 6W731X367QClass: ACTIBQuantity: 1.25 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT