Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020328
Company: ORGANON USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMEGON MENOTROPINS (FSH;LH) 75 IU/VIAL;75 IU/VIAL INJECTABLE;INJECTION Discontinued None No No
HUMEGON MENOTROPINS (FSH;LH) 150 IU/VIAL;150 IU/VIAL INJECTABLE;INJECTION Discontinued None No 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
09/01/1994 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
11/23/1999 SUPPL-4 Labeling

Label is not available on this site.

04/02/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/21/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/06/1995 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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