BLA 17646, held by Serono. Menotropins (Fsh;Lh).
As of Nov 13, 2026, BLA 17646 (Pergonal), held by Serono, was first approved by FDA on Aug 22, 1975, with 34 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 23, 1989 | Supplement 21Efficacy (new indication or use) | Approved | None posted |
| Aug 22, 1975 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pergonal75 IU/AMP;75 IU/AMP · injectable;injection | Menotropins (Fsh;Lh) | Discontinued |
| Pergonal150 IU/AMP;150 IU/AMP · injectable;injection | Menotropins (Fsh;Lh) | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 30, 2002 | Supplement 49Labeling · Standard review | Approved | |
| Dec 20, 2001 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Oct 12, 2000 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Aug 31, 2000 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| May 20, 1999 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1998 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1998 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Aug 22, 1996 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Jan 22, 1996 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Apr 5, 1995 | Supplement 39Labeling · Standard review | Approved | None posted |
| Oct 31, 1994 | Supplement 38Labeling · Standard review | Approved | None posted |
| Oct 21, 1994 | Supplement 36Labeling · Standard review | Approved | None posted |
| May 31, 1994 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Dec 6, 1993 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1993 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Jan 17, 1991 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1990 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Aug 23, 1989 | Supplement 21Efficacy (new indication or use) | Approved | None posted |
| Apr 18, 1988 | Supplement 28Labeling | Approved | None posted |
| Dec 4, 1987 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1986 | Supplement 20Labeling | Approved | None posted |
| Mar 18, 1986 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Aug 23, 1985 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jul 29, 1985 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| May 20, 1985 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| May 20, 1985 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1983 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1983 | Supplement 14Labeling | Approved | None posted |
| Jul 11, 1983 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 11, 1982 | Supplement 13Labeling | Approved | None posted |
| Jan 20, 1982 | Supplement 1Labeling | Approved | None posted |
| Oct 22, 1981 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Oct 28, 1980 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1979 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Aug 22, 1975 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
