Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Pfizer INC
113480771
Manufacturing Establishments4
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
AndersonBrecon Inc.
U.S. Pharmaceuticals
Pfizer INC
053217022
PENN PHARMACEUTICAL SERVICES LIMITED
U.S. Pharmaceuticals
Pfizer INC
226277259
Porton Pharma Solutions Ltd
U.S. Pharmaceuticals
Pfizer INC
528192390
AMPAC Fine Chemicals LLC
U.S. Pharmaceuticals
Pfizer INC
073903937
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Velsipity
Product Details
NDC Product Code
63539-274Application Number
NDA216956Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
November 17, 2023MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Etrasimod ArginineActive
Code: MXE5EMA09LClass: ACTIMQuantity: 2 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4DClass: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JMClass: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584Class: IACT
FD&C YELLOW NO. 5 ALUMINUM LAKEInactive
Code: JQ6BLH9FR7Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT