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Generated: May 26, 2017

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Details for New Drug Application (NDA): 019938

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NDA 019938 describes NOVOLIN R, which is a drug marketed by Novo Nordisk Inc and is included in two NDAs. It is available from three suppliers. Additional details are available on the NOVOLIN R profile page.

The generic ingredient in NOVOLIN R is insulin recombinant purified human. There are thirty-eight drug master file entries for this compound. Additional details are available on the insulin recombinant purified human profile page.

Summary for NDA: 019938

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 019938

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
insulin recombinant human
INJECTABLE;INJECTION 019938 NDA Novo Nordisk 0169-1833 0169-1833-02 1 VIAL in 1 CARTON (0169-1833-02) > 10 mL in 1 VIAL
insulin recombinant human
INJECTABLE;INJECTION 019938 NDA Novo Nordisk 0169-1833 0169-1833-11 1 VIAL in 1 CARTON (0169-1833-11) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:INJECTABLE;INJECTIONStrength100 UNITS/ML
Approval Date:Jun 25, 1991TE:RLD:Yes

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