MedPath
FDA Approval

NovoLog Mix 70/30

November 8, 2010

HUMAN PRESCRIPTION DRUG LABEL

Insulin aspart(100 [iU] in 1 mL)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products (2)

NovoLog Mix 70/30

54868-5327

NDA021172

NDA (C73594)

SUBCUTANEOUS

June 15, 2011

SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2TClass: IACTQuantity: 1.25 mg in 1 mL
Code: D933668QVXClass: ACTIBQuantity: 100 [iU] in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 16 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
METACRESOLInactive
Code: GGO4Y809LOClass: IACTQuantity: 1.72 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 1.5 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.877 mg in 1 mL
ZINCInactive
Code: J41CSQ7QDSClass: IACTQuantity: 19.6 ug in 1 mL
PROTAMINE SULFATEInactive
Code: 0DE9724IHCClass: IACTQuantity: 0.32 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

NovoLog Mix 70/30

54868-5201

NDA021172

NDA (C73594)

SUBCUTANEOUS

June 15, 2011

MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 36.4 mg in 1 mL
Code: D933668QVXClass: ACTIBQuantity: 100 [iU] in 1 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2TClass: IACTQuantity: 1.25 mg in 1 mL
METACRESOLInactive
Code: GGO4Y809LOClass: IACTQuantity: 1.72 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 1.5 mg in 1 mL
PROTAMINE SULFATEInactive
Code: 0DE9724IHCClass: IACTQuantity: 0.32 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 0.58 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
ZINCInactive
Code: J41CSQ7QDSClass: IACTQuantity: 19.6 ug in 1 mL
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