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Details for New Drug Application (NDA): 021810

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NDA 021810 describes NOVOLOG MIX 50/50, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. There is one patent protecting this drug. Additional details are available on the NOVOLOG MIX 50/50 profile page.

The generic ingredient in NOVOLOG MIX 50/50 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: 021810

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength50 UNITS/ML;50 UNITS/ML
Approval Date:Aug 26, 2008TE:RLD:No
Patent:5,866,538*PEDPatent Expiration:Dec 20, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021810

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
NOVOLOG MIX 50/50
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021810-001Aug 26, 20085,547,930► subscribe
Novo Nordisk Inc
NOVOLOG MIX 50/50
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021810-001Aug 26, 20085,840,680► subscribe
Novo Nordisk Inc
NOVOLOG MIX 50/50
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021810-001Aug 26, 20085,834,422► subscribe
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