Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019863
Company: EMD SERONO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GEREF SERMORELIN ACETATE EQ 0.05MG BASE/AMP **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/28/1990 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/02/2001 SUPPL-6 Labeling

Label is not available on this site.

03/27/1998 SUPPL-5 Labeling

Label is not available on this site.

04/03/1998 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1991 SUPPL-2 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019863_S002_Geref.pdf
08/26/1991 SUPPL-1 Manufacturing (CMC)-Expiration Date Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019863_S001_GEREF.pdf

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