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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


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0.05MG BASE/AMP **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:Yes

Expired Orange Book Patents for NDA: 019863

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
sermorelin acetate
INJECTABLE;INJECTION019863-001Dec 28, 19904,517,181► Subscribe
Emd Serono
sermorelin acetate
INJECTABLE;INJECTION019863-001Dec 28, 19904,703,035► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.