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Details for New Drug Application (NDA): 020522

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NDA 020522 describes NUTROPIN AQ PEN, which is a drug marketed by Genentech and is included in one NDA. It is available from one supplier. Additional details are available on the NUTROPIN AQ PEN profile page.

The generic ingredient in NUTROPIN AQ PEN 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: 020522

Tradename:
NUTROPIN AQ
Applicant:
Genentech
Ingredient:
somatropin recombinant
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020522

Suppliers and Packaging for NDA: 020522

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUTROPIN AQ
somatropin recombinant
INJECTABLE;INJECTION 020522 NDA Genentech, Inc. 50242-043 50242-043-14 1 CARTRIDGE in 1 CARTON (50242-043-14) > 2 mL in 1 CARTRIDGE
NUTROPIN AQ
somatropin recombinant
INJECTABLE;INJECTION 020522 NDA Genentech, Inc. 50242-073 50242-073-01 1 CARTRIDGE in 1 CARTON (50242-073-01) > 2 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/2ML (5MG/ML)
Approval Date:Dec 29, 1995TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/2ML (5MG/ML)
Approval Date:Apr 22, 2002TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/2ML (2.5MG/ML)
Approval Date:Jan 3, 2008TE:RLD:Yes

Expired Orange Book Patents for NDA: 020522

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genentech
NUTROPIN AQ
somatropin recombinant
INJECTABLE;INJECTION020522-001Dec 29, 19955,763,394► subscribe
Genentech
NUTROPIN AQ PEN
somatropin recombinant
INJECTABLE;INJECTION020522-002Apr 22, 20025,763,394► subscribe
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