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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
Chartwell RX, LLC.
DUNS: 079394054
Effective Date
October 3, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Calcium acetate(667 mg in 1 1)

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
62135-191
Application Number
ANDA091312
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 3, 2023
GLYCINEInactive
Code: TE7660XO1CClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
DIMETHICONE 350Inactive
Code: 2Y53S6ATLUClass: IACT
SILICA, TRIMETHYLSILYL CAPPEDInactive
Code: VU10KU4B9SClass: IACT
Code: Y882YXF34XClass: ACTIBQuantity: 667 mg in 1 1
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