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Details for New Drug Application (NDA): 021017

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NDA 021017 describes HUMALOG MIX 75/25 PEN, which is a drug marketed by Lilly and is included in one NDA. It is available from two suppliers. Additional details are available on the HUMALOG MIX 75/25 PEN profile page.

The generic ingredient in HUMALOG MIX 75/25 PEN is insulin lispro protamine recombinant; insulin lispro 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 lispro protamine recombinant; insulin lispro recombinant profile page.

Summary for NDA: 021017

Pharmacology for NDA: 021017

Ingredient-typeInsulin

Suppliers and Packaging for NDA: 021017

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HUMALOG MIX 75/25
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION 021017 NDA Eli Lilly and Company 0002-7511 0002-7511-01 1 VIAL in 1 CARTON (0002-7511-01) > 10 mL in 1 VIAL
HUMALOG MIX 75/25
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION 021017 NDA Eli Lilly and Company 0002-7511 0002-7511-99 1 VIAL in 1 CARTON (0002-7511-99) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength75 UNITS/ML;25 UNITS/ML
Approval Date:Dec 22, 1999TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength75 UNITS/ML;25 UNITS/ML
Approval Date:Sep 6, 2007TE:RLD:Yes
Patent:7,291,132Patent Expiration:Aug 9, 2024Product Flag?YSubstance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength75 UNITS/ML;25 UNITS/ML
Approval Date:Dec 22, 1999TE:RLD:No

Expired Orange Book Patents for NDA: 021017

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
HUMALOG MIX 75/25
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021017-001Dec 22, 19995,461,031► subscribe
Lilly
HUMALOG MIX 75/25 KWIKPEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021017-002Sep 6, 20075,461,031► subscribe
Lilly
HUMALOG MIX 75/25 KWIKPEN
insulin lispro protamine recombinant; insulin lispro recombinant
INJECTABLE;INJECTION021017-002Sep 6, 20075,514,646► 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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