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Calcium Acetate

These highlights do not include all the information needed to use calcium acetate capsules safely and effectively. See full prescribing information for calcium acetate capsules. Calcium Acetate Capsules, 667 mg Initial U.S. Approval: 1990

Approved
Approval ID

2b6d52a5-8742-4dd4-a9d5-dd65544e13c1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 29, 2014

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Calcium Acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53808-1001
Application NumberANDA203135
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcium Acetate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2014
FDA Product Classification

INGREDIENTS (8)

FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
CALCIUM ACETATEActive
Quantity: 667 mg in 1 1
Code: Y882YXF34X
Classification: ACTIB
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROUS OXIDEInactive
Code: G7036X8B5H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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Calcium Acetate - FDA Drug Approval Details