Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 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 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
12/20/2001 SUPPL-51 Supplement

Label is not available on this site.

07/30/2002 SUPPL-49 Supplement 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 Supplement

Label is not available on this site.

10/12/2000 SUPPL-47 Supplement

Label is not available on this site.

05/20/1999 SUPPL-46 Supplement

Label is not available on this site.

02/17/1998 SUPPL-44 Supplement

Label is not available on this site.

02/18/1998 SUPPL-43 Supplement

Label is not available on this site.

08/22/1996 SUPPL-42 Supplement

Label is not available on this site.

01/22/1996 SUPPL-40 Supplement

Label is not available on this site.

04/05/1995 SUPPL-39 Supplement

Label is not available on this site.

10/31/1994 SUPPL-38 Supplement

Label is not available on this site.

12/06/1993 SUPPL-37 Supplement

Label is not available on this site.

10/21/1994 SUPPL-36 Supplement

Label is not available on this site.

06/09/1993 SUPPL-33 Supplement

Label is not available on this site.

05/31/1994 SUPPL-32 Supplement

Label is not available on this site.

01/17/1991 SUPPL-31 Supplement

Label is not available on this site.

02/28/1990 SUPPL-29 Supplement

Label is not available on this site.

04/18/1988 SUPPL-28 Supplement

Label is not available on this site.

12/04/1987 SUPPL-27 Supplement

Label is not available on this site.

03/18/1986 SUPPL-26 Supplement

Label is not available on this site.

08/23/1985 SUPPL-25 Supplement

Label is not available on this site.

05/20/1985 SUPPL-24 Supplement

Label is not available on this site.

07/29/1985 SUPPL-23 Supplement

Label is not available on this site.

05/20/1985 SUPPL-22 Supplement

Label is not available on this site.

08/23/1989 SUPPL-21 Supplement

Label is not available on this site.

09/15/1986 SUPPL-20 Supplement

Label is not available on this site.

07/18/1983 SUPPL-18 Supplement

Label is not available on this site.

07/11/1983 SUPPL-16 Supplement

Label is not available on this site.

07/18/1983 SUPPL-14 Supplement

Label is not available on this site.

02/11/1982 SUPPL-13 Supplement

Label is not available on this site.

10/22/1981 SUPPL-11 Supplement

Label is not available on this site.

10/28/1980 SUPPL-10 Supplement

Label is not available on this site.

10/26/1979 SUPPL-5 Supplement

Label is not available on this site.

01/20/1982 SUPPL-1 Supplement

Label is not available on this site.

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