Phoslo
Approved
Approval ID
6b0e60bb-0e9a-45a7-8f92-a43d939f8deb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 10, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-3460
Application NumberNDA021160
Product Classification
M
Marketing Category
C73594
G
Generic Name
Calcium Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2011
FDA Product Classification
INGREDIENTS (6)
CALCIUM ACETATEActive
Quantity: 667 mg in 1 1
Code: Y882YXF34X
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
Calcium Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5691
Application NumberNDA021160
Product Classification
M
Marketing Category
C73594
G
Generic Name
Calcium Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2011
FDA Product Classification
INGREDIENTS (6)
CALCIUM ACETATEActive
Quantity: 667 mg in 1 1
Code: Y882YXF34X
Classification: ACTIB
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT