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FDA Approval

Phoslo

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

FDA Approval Summary

Company
Effective Date
March 10, 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.

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products2

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

Phoslo

Product Details

NDC Product Code
54868-3460
Application Number
NDA021160
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
January 6, 2011
Code: Y882YXF34XClass: ACTIBQuantity: 667 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT

Phoslo

Product Details

NDC Product Code
54868-5691
Application Number
NDA021160
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
January 6, 2011
Code: Y882YXF34XClass: ACTIBQuantity: 667 mg in 1 1
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
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