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Generated: November 20, 2018

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Details for New Drug Application (NDA): 019640

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NDA 019640 describes HUMATROPE, which is a drug marketed by Lilly and is included in one NDA. It is available from one supplier. Additional details are available on the HUMATROPE profile page.

The generic ingredient in HUMATROPE is somatropin recombinant. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the somatropin recombinant profile page.
Summary for 019640
Tradename:HUMATROPE
Applicant:Lilly
Ingredient:somatropin recombinant
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019640
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HUMATROPE somatropin recombinant INJECTABLE;INJECTION 019640 NDA Eli Lilly and Company 0002-7335 0002-7335-11 1 KIT in 1 CARTON (0002-7335-11) * 5 mL in 1 VIAL (0002-7349-01) * 5 mL in 1 VIAL (0002-7336-01)
HUMATROPE somatropin recombinant INJECTABLE;INJECTION 019640 NDA Eli Lilly and Company 0002-8147 0002-8147-01 1 TRAY in 1 CARTON (0002-8147-01) > 1 KIT in 1 TRAY * 2.88 mL in 1 CARTRIDGE (0002-7554-01) * 2.88 mL in 1 SYRINGE (0002-7618-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2MG/VIAL
Approval Date:Jun 23, 1987TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/VIAL
Approval Date:Mar 8, 1987TE:BXRLD:Yes

Profile for product number 005

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/VIAL
Approval Date:Feb 4, 1999TE:BXRLD:Yes

Expired US Patents for NDA 019640

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly HUMATROPE somatropin recombinant INJECTABLE;INJECTION 019640-004 Mar 8, 1987 ➤ Sign Up ➤ Sign Up
Lilly HUMATROPE somatropin recombinant INJECTABLE;INJECTION 019640-007 Feb 4, 1999 ➤ Sign Up ➤ Sign Up
Lilly HUMATROPE somatropin recombinant INJECTABLE;INJECTION 019640-006 Feb 4, 1999 ➤ Sign Up ➤ Sign Up
Lilly HUMATROPE somatropin recombinant INJECTABLE;INJECTION 019640-005 Feb 4, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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