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Generated: May 23, 2019

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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 forty 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 018780
Ingredient:insulin human
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
HUMULIN R 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
HUMULIN R 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

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 004

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

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Serving hundreds of leading biopharmaceutical companies globally:

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