Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017646
Company: SERONO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERGONAL MENOTROPINS (FSH;LH) 75 IU/AMP;75 IU/AMP INJECTABLE;INJECTION Discontinued None No No
PERGONAL MENOTROPINS (FSH;LH) 150 IU/AMP;150 IU/AMP 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
08/22/1975 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
12/20/2001 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/2002 SUPPL-49 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17646s049ltr.pdf
08/31/2000 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

10/12/2000 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1999 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

02/17/1998 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1998 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1996 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

01/22/1996 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

04/05/1995 SUPPL-39 Labeling

Label is not available on this site.

10/31/1994 SUPPL-38 Labeling

Label is not available on this site.

12/06/1993 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1994 SUPPL-36 Labeling

Label is not available on this site.

06/09/1993 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1994 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/17/1991 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/28/1990 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/18/1988 SUPPL-28 Labeling

Label is not available on this site.

12/04/1987 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1986 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1985 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1985 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/29/1985 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/20/1985 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/23/1989 SUPPL-21 Efficacy-New Indication

Label is not available on this site.

09/15/1986 SUPPL-20 Labeling

Label is not available on this site.

07/18/1983 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1983 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1983 SUPPL-14 Labeling

Label is not available on this site.

02/11/1982 SUPPL-13 Labeling

Label is not available on this site.

10/22/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1980 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1979 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/20/1982 SUPPL-1 Labeling

Label is not available on this site.

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