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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 two suppliers. There is one patent protecting this drug. 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 thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the insulin aspart protamine recombinant; insulin aspart recombinant profile page.

Summary for NDA: 021172

Pharmacology for NDA: 021172

Ingredient-typeInsulin

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

Summary 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
Patent:5,866,538*PEDPatent Expiration:Dec 19, 2017Product Flag?Substance Flag?Delist Request?Y

Summary 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
Patent:5,866,538*PEDPatent Expiration:Dec 19, 2017Product Flag?Substance Flag?Delist Request?Y

Summary 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
Patent:5,866,538*PEDPatent Expiration:Dec 19, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021172

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-003Nov 1, 20015,547,930► subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-002Nov 1, 20015,834,422► subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-002Nov 1, 20015,547,930► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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