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Details for New Drug Application (NDA): 019774

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NDA 019774 describes ZOMACTON, which is a drug marketed by Ferring and is included in one NDA. It is available from one supplier. Additional details are available on the ZOMACTON profile page.

The generic ingredient in ZOMACTON 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: 019774

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 019774

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
somatropin recombinant
INJECTABLE;INJECTION 019774 NDA Ferring Pharmaceuticals Inc. 55566-1801 55566-1801-1 1 KIT in 1 CARTON (55566-1801-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 5 mL in 1 VIAL
somatropin recombinant
INJECTABLE;INJECTION 019774 NDA Ferring Pharmaceuticals Inc. 55566-1901 55566-1901-1 1 KIT in 1 CARTON (55566-1901-1) * 1 mL in 1 VIAL * 1 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength4.8MG/VIAL
Approval Date:May 25, 1995TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/VIAL
Approval Date:Jan 4, 2002TE:BXRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/VIAL
Approval Date:Mar 7, 2012TE:BXRLD:Yes

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