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FDA Approval

Calcium Acetate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Effective Date
March 12, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Calcium acetate(667 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

State of Florida DOH Central Pharmacy

State of Florida DOH Central Pharmacy

829348114

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
53808-0216
Application Number
ANDA077728
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 12, 2010
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
Code: Y882YXF34XClass: ACTIBQuantity: 667 mg in 1 1
GELATINInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
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