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FDA NDA · NDA019863

GEREF

Sponsor: EMD SERONO

APPLICATION
NDA019863
TYPE
NDA
ORIGINAL APPROVAL
1990-12-28
LATEST ACTION
2001-10-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

GEREF · ReferenceDiscontinued
SERMORELIN ACETATE EQ 0.05MG BASE/AMP **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2001-10-02Labeling · Supplement 6 · standardAP
1998-04-03Manufacturing (CMC) · Supplement 4 · standardAP
1998-03-27Labeling · Supplement 5 · standardAP
1991-08-26Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1991-05-28Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
1990-12-28Type 1 - New Molecular Entity · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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