Manufacturing Establishments4
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
PENN PHARMACEUTICAL SERVICES LIMITED
Pfizer Laboratories Div Pfizer Inc
226277259
Porton Pharma Solutions Ltd
Pfizer Laboratories Div Pfizer Inc
528192390
AMPAC Fine Chemicals LLC
Pfizer Laboratories Div Pfizer Inc
073903937
AndersonBrecon Inc.
Pfizer Laboratories Div Pfizer Inc
053217022
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
0069-0274Application Number
NDA216956Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 18, 2023Etrasimod ArginineActive
Code: MXE5EMA09LClass: ACTIMQuantity: 2 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: 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
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C YELLOW NO. 5 ALUMINUM LAKEInactive
Code: JQ6BLH9FR7Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT