Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019415
Company: SERONO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FERTINEX UROFOLLITROPIN 150 IU/AMP INJECTABLE;SUBCUTANEOUS Discontinued None No No
FERTINEX UROFOLLITROPIN 75 IU/AMP INJECTABLE;SUBCUTANEOUS Discontinued None No No
METRODIN UROFOLLITROPIN 75 IU/AMP INJECTABLE;INTRAMUSCULAR Discontinued None No No
METRODIN UROFOLLITROPIN 150 IU/AMP INJECTABLE;INTRAMUSCULAR 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
09/18/1986 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/15/2002 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/2000 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

06/19/2000 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/2000 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/18/2000 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/2000 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/01/1999 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1999 SUPPL-21 Labeling

Label is not available on this site.

04/15/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/18/1998 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/22/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/12/1995 SUPPL-14 Labeling

Label is not available on this site.

08/29/1995 SUPPL-13 Efficacy-New Dosing Regimen

Label is not available on this site.

12/06/1993 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1994 SUPPL-11 Labeling

Label is not available on this site.

03/28/1994 SUPPL-10 Labeling

Label is not available on this site.

08/23/1996 SUPPL-9 Efficacy-New Route Of Administration

Label is not available on this site.

05/31/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/17/1991 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/1990 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/25/1988 SUPPL-2 Labeling

Label is not available on this site.

03/01/1988 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

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