Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 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 N/A

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 Supplement

Label is not available on this site.

04/02/1999 SUPPL-3 Supplement

Label is not available on this site.

02/21/1997 SUPPL-2 Supplement

Label is not available on this site.

07/06/1995 SUPPL-1 Supplement

Label is not available on this site.

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