Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
INVAGEN PHARMACEUTICALS, INC.
165104469
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
InvaGen Pharmaceuticals, Inc.
EXELAN PHARMACEUTICALS, INC.
INVAGEN PHARMACEUTICALS, INC.
080334903
Avema Pharma Solutions
EXELAN PHARMACEUTICALS, INC.
INVAGEN PHARMACEUTICALS, INC.
804087794
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calcium Acetate
Product Details
NDC Product Code
76282-377Application Number
ANDA203135Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 1, 2021SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
Calcium acetateActive
Code: Y882YXF34XClass: ACTIBQuantity: 667 mg in 1 1
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT