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Details for New Drug Application (NDA): 018780

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NDA 018780 describes HUMULIN R KWIKPEN, 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 HUMULIN R KWIKPEN profile page.

The generic ingredient in HUMULIN R KWIKPEN is insulin human. 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 human profile page.

Summary for NDA: 018780

Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 018780


Suppliers and Packaging for NDA: 018780

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
insulin recombinant human
INJECTABLE;INJECTION 018780 NDA Eli Lilly and Company 0002-8215 0002-8215-01 1 VIAL in 1 CARTON (0002-8215-01) > 10 mL in 1 VIAL
insulin recombinant human
INJECTABLE;INJECTION 018780 NDA Eli Lilly and Company 0002-8215 0002-8215-17 1 VIAL in 1 CARTON (0002-8215-17) > 3 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:INJECTABLE;INJECTIONStrength100 UNITS/ML
Approval Date:Oct 28, 1982TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength1500 UNITS/3ML (500 UNITS/ML)
Approval Date:Dec 29, 2015TE:RLD:Yes

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength10000 UNITS/20ML (500 UNITS/ML)
Approval Date:Mar 31, 1994TE:RLD:Yes
Patent:7,291,132Patent Expiration:Aug 9, 2024Product Flag?YSubstance Flag?Delist Request?

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