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Details for New Drug Application (NDA): 019721

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NDA 019721 describes NORDITROPIN, which is a drug marketed by Novo Nordisk Inc and is included in two NDAs. It is available from two suppliers. There are fourteen patents protecting this drug. Additional details are available on the NORDITROPIN profile page.

The generic ingredient in NORDITROPIN 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: 019721

Novo Nordisk Inc
somatropin recombinant

Summary for product number 001

Approval Date:May 8, 1995TE:RLD:No

Summary for product number 002

Approval Date:May 8, 1995TE:RLD:No

Expired Orange Book Patents for NDA: 019721

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
somatropin recombinant
INJECTABLE;INJECTION019721-001May 8, 19955,633,352► subscribe
Novo Nordisk Inc
somatropin recombinant
INJECTABLE;INJECTION019721-002May 8, 19955,633,352► subscribe
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