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Last Updated: October 19, 2019

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Details for New Drug Application (NDA): 021172

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NDA 021172 describes NOVOLOG MIX 70/30 PENFILL, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from four suppliers. Additional details are available on the NOVOLOG MIX 70/30 PENFILL profile page.

The generic ingredient in NOVOLOG MIX 70/30 PENFILL is insulin aspart protamine recombinant; insulin aspart recombinant. There are forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the insulin aspart protamine recombinant; insulin aspart recombinant profile page.
Pharmacology for NDA: 021172
Suppliers and Packaging for NDA: 021172
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOVOLOG MIX 70/30 insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172 NDA Novo Nordisk 0169-3685 0169-3685-12 1 VIAL, GLASS in 1 CARTON (0169-3685-12) > 10 mL in 1 VIAL, GLASS
NOVOLOG MIX 70/30 insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172 NDA Novo Nordisk 0169-3685 0169-3685-92 1 VIAL, GLASS in 1 CARTON (0169-3685-92) > 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength700 UNITS/10ML; 300 UNITS/10ML (70 UNITS/ML; 30 UNITS/ML)
Approval Date:Nov 1, 2001TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)
Approval Date:Nov 1, 2001TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)
Approval Date:Nov 1, 2001TE:RLD:No

Expired US Patents for NDA 021172

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