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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

Company
Effective Date
October 19, 2022
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.

Suven Pharmaceuticals Limited

Rising Pharma Holdings, Inc.

677604288

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
16571-813
Application Number
ANDA211038
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 19, 2022
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACTQuantity: 0.0061 mg in 1 1
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACTQuantity: 0.0555 mg in 1 1
WATERInactive
Code: 059QF0KO0RClass: IACTQuantity: 13.9592 mg in 1 1
Code: Y882YXF34XClass: ACTIBQuantity: 667 mg in 1 1
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JMClass: IACTQuantity: 0.0728 mg in 1 1
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