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Medtronic
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Generated: August 18, 2017

DrugPatentWatch Database Preview

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. Eight suppliers are listed for this compound. Additional details are available on the somatropin recombinant profile page.

Summary for NDA: 019640

Tradename:
1
Applicant:
1
Ingredient:
1
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)

Summary for product number 001

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

Summary for product number 004

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

Summary for product number 005

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

Expired Orange Book Patents for NDA: 019640

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
HUMATROPE
somatropin recombinant
INJECTABLE;INJECTION019640-004Mar 8, 1987► Subscribe► Subscribe
Lilly
HUMATROPE
somatropin recombinant
INJECTABLE;INJECTION019640-006Feb 4, 1999► Subscribe► Subscribe
Lilly
HUMATROPE
somatropin recombinant
INJECTABLE;INJECTION019640-005Feb 4, 1999► Subscribe► Subscribe
Lilly
HUMATROPE
somatropin recombinant
INJECTABLE;INJECTION019640-007Feb 4, 1999► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Farmers Insurance
Mallinckrodt
Merck
Argus Health
Queensland Health
US Army
QuintilesIMS
Johnson and Johnson

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