Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
LUPIN PHARMA
965791259
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
LUPIN LIMITED
LUPIN LIMITED
LUPIN PHARMA
677600414
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
57297-134Application Number
ANDA202127Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 17, 2016D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
Calcium acetateActive
Code: Y882YXF34XClass: ACTIBQuantity: 667 mg in 1 1
SHELLACInactive
Code: 46N107B71OClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT