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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 thirty-eight 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 NDA: 020563

Tradename:
HUMALOG
Applicant:
Lilly
Ingredient:
insulin lispro recombinant
Patents:1

Pharmacology for NDA: 020563

Ingredient-typeInsulin

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100 UNITS/ML
Approval Date:Jun 14, 1996TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 12, 2015
Regulatory Exclusivity Use:NEW ROUTE

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100 UNITS/ML
Approval Date:Aug 6, 1998TE:RLD:No
Regulatory Exclusivity Expiration:Oct 12, 2015
Regulatory Exclusivity Use:NEW ROUTE

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100 UNITS/ML
Approval Date:Sep 6, 2007TE:RLD:Yes
Patent:7,291,132Patent Expiration:Aug 9, 2024Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020563

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
HUMALOG
insulin lispro recombinant
INJECTABLE;INJECTION020563-001Jun 14, 19965,474,978► subscribe
Lilly
HUMALOG KWIKPEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-003Sep 6, 20075,514,646► subscribe
Lilly
HUMALOG PEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-002Aug 6, 19985,514,646► subscribe
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