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Generated: January 18, 2019

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Details for New Drug Application (NDA): 020563

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NDA 020563 describes HUMALOG PEN, which is a drug marketed by Lilly and is included in one NDA. It is available from four suppliers. Additional details are available on the HUMALOG PEN profile page.

The generic ingredient in HUMALOG PEN is insulin lispro 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 lispro recombinant profile page.
Summary for 020563
Tradename:HUMALOG PEN
Applicant:Lilly
Ingredient:insulin lispro recombinant
Patents:1
Pharmacology for NDA: 020563
Ingredient-typeInsulin
Medical Subject Heading (MeSH) Categories for 020563
Suppliers and Packaging for NDA: 020563
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HUMALOG insulin lispro recombinant INJECTABLE;INJECTION 020563 NDA Eli Lilly and Company 0002-7510 0002-7510-01 1 VIAL in 1 CARTON (0002-7510-01) > 10 mL in 1 VIAL
HUMALOG insulin lispro recombinant INJECTABLE;INJECTION 020563 NDA Eli Lilly and Company 0002-7510 0002-7510-17 1 VIAL in 1 CARTON (0002-7510-17) > 3 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100 UNITS/ML
Approval Date:Jun 14, 1996TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100 UNITS/ML
Approval Date:Aug 6, 1998TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100 UNITS/ML
Approval Date:Sep 6, 2007TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 9, 2024Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 020563

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly HUMALOG PEN insulin lispro recombinant INJECTABLE;INJECTION 020563-002 Aug 6, 1998 ➤ Sign Up ➤ Sign Up
Lilly HUMALOG insulin lispro recombinant INJECTABLE;INJECTION 020563-001 Jun 14, 1996 ➤ Sign Up ➤ Sign Up
Lilly HUMALOG insulin lispro recombinant INJECTABLE;INJECTION 020563-001 Jun 14, 1996 ➤ Sign Up ➤ Sign Up
Lilly HUMALOG PEN insulin lispro recombinant INJECTABLE;INJECTION 020563-002 Aug 6, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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