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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021426

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NDA 021426 describes OMNITROPE, which is a drug marketed by Sandoz and is included in one NDA. It is available from one supplier. Additional details are available on the OMNITROPE profile page.

The generic ingredient in OMNITROPE is somatropin recombinant. There are four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the somatropin recombinant profile page.
Summary for 021426
Tradename:OMNITROPE
Applicant:Sandoz
Ingredient:somatropin recombinant
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021426
Suppliers and Packaging for NDA: 021426
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMNITROPE somatropin recombinant INJECTABLE;INJECTION 021426 NDA Sandoz Inc 0781-3001 N 0781-3001-07
OMNITROPE somatropin recombinant INJECTABLE;INJECTION 021426 NDA Sandoz Inc 0781-3001 N 0781-3001-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5.8MG/VIAL
Approval Date:May 30, 2006TE:BXRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1.5MG/VIAL
Approval Date:May 30, 2006TE:BXRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/1.5ML
Approval Date:Jan 16, 2008TE:BXRLD:No

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McKinsey
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