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Details for New Drug Application (NDA): 019863

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NDA 019863 describes GEREF, which is a drug marketed by Emd Serono Inc and Emd Serono and is included in two NDAs. Additional details are available on the GEREF profile page.

The generic ingredient in GEREF is sermorelin acetate. There is one drug master file entry for this compound. Additional details are available on the sermorelin acetate profile page.

Summary for NDA: 019863

Tradename:
GEREF
Applicant:
Emd Serono
Ingredient:
sermorelin acetate
Patents:0

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/AMP **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 28, 1990TE:RLD:No

Expired Orange Book Patents for NDA: 019863

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
GEREF
sermorelin acetate
INJECTABLE;INJECTION019863-001Dec 28, 19904,517,181► subscribe
Emd Serono
GEREF
sermorelin acetate
INJECTABLE;INJECTION019863-001Dec 28, 19904,703,035► subscribe
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