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Details for New Drug Application (NDA): 021075

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NDA 021075 describes NUTROPIN DEPOT, which is a drug marketed by Genentech and is included in one NDA. Additional details are available on the NUTROPIN DEPOT profile page.

The generic ingredient in NUTROPIN DEPOT 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: 021075

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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength13.5MG/VIAL
Approval Date:Dec 22, 1999TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength18MG/VIAL
Approval Date:Dec 22, 1999TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength22.5MG/VIAL
Approval Date:Dec 22, 1999TE:RLD:No

Expired Orange Book Patents for NDA: 021075

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genentech
NUTROPIN DEPOT
somatropin recombinant
INJECTABLE;INJECTION021075-003Dec 22, 19995,912,015► subscribe
Genentech
NUTROPIN DEPOT
somatropin recombinant
INJECTABLE;INJECTION021075-001Dec 22, 19995,654,010► subscribe
Genentech
NUTROPIN DEPOT
somatropin recombinant
INJECTABLE;INJECTION021075-002Dec 22, 19995,654,010► subscribe
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