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FDA Approval

Cefprozil

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

FDA Approval Summary

Company
Effective Date
August 31, 2018
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cefprozil(500 mg in 1 1)

Products2

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

Cefprozil

Product Details

NDC Product Code
0093-1078
Application Number
ANDA065208
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 31, 2018
CefprozilActive
Code: 4W0459ZA4VClass: ACTIMQuantity: 500 mg in 1 1
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT

Cefprozil

Product Details

NDC Product Code
0093-1077
Application Number
ANDA065208
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 31, 2018
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
CefprozilActive
Code: 4W0459ZA4VClass: ACTIMQuantity: 250 mg in 1 1
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
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