NDA 17962, held by Esjay Pharma. Bromocriptine Mesylate.
As of Nov 13, 2026, NDA 17962 (Parlodel), held by Esjay Pharma, was first approved by FDA on Jun 28, 1978, with 68 approved supplements and 0 published complete response letters.
Bromocriptine mesylate is an ergot derivative indicated for the treatment of: Hyperprolactinemia-associated dysfunction including amenorrhea with or without galactorrhea, infertility, or hypogonadism in adults Prolactin-secreting adenomas in adults and pediatric patients 11 years of age and older. Acromegaly in adults. Signs and symptoms of idiopathic Parkinson’s disease or postencephalitic parkinsonism in adults. Limitations of Use Avoid use of bromocriptine mesylate for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions (1.1, 5.4) 1.
| Jun 28, 1985 | Supplement 18Efficacy (new indication or use) | Approved | None posted |
| Jun 28, 1978 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| ParlodelEQ 2.5MG BASE · tablet;oral | Bromocriptine Mesylate | RxReference drug |
| ParlodelEQ 5MG BASE · capsule;oral | Bromocriptine Mesylate | RxReference drug |
| Jun 30, 2026 | Supplement 80Labeling · Standard review | Approved | |
| Jun 30, 2026 | Supplement 89Labeling · Standard review | Approved | |
| Jul 12, 2021 | Supplement 83Labeling · Standard review | Approved | |
| Dec 13, 2019 | Supplement 81Labeling · Standard review | Approved | |
| Jun 13, 2016 | Supplement 74Manufacturing · Priority review | Approved | None posted |
| Nov 26, 2014 | Supplement 75Manufacturing · Priority review | Approved | None posted |
| Feb 27, 2014 | Supplement 72Manufacturing · Priority review | Approved | None posted |
| Jul 31, 2013 | Supplement 71Manufacturing · Priority review | Approved | None posted |
| Jan 5, 2012 | Supplement 65Labeling · Standard review | Approved | |
| Jan 5, 2012 | Supplement 68Labeling | Approved | |
| Nov 9, 2005 | Supplement 63Labeling · Standard review | Approved | |
| Nov 9, 2005 | Supplement 64Labeling · Standard review | Approved | |
| Feb 21, 2002 | Supplement 62Manufacturing · Priority review | Approved | None posted |
| Nov 20, 2001 | Supplement 61Manufacturing · Priority review | Approved | None posted |
| May 22, 2001 | Supplement 60Manufacturing · Priority review | Approved | None posted |
| May 1, 2000 | Supplement 59Manufacturing · Priority review | Approved | None posted |
| Nov 9, 1999 | Supplement 53Labeling · Standard review | Approved | None posted |
| Oct 1, 1999 | Supplement 58Manufacturing · Priority review | Approved | None posted |
| Sep 10, 1999 | Supplement 57Manufacturing · Priority review | Approved | None posted |
| Apr 22, 1999 | Supplement 56Manufacturing · Priority review | Approved | None posted |
| Sep 3, 1998 | Supplement 55Manufacturing · Priority review | Approved | None posted |
| Aug 13, 1998 | Supplement 54Manufacturing · Priority review | Approved | None posted |
| Apr 2, 1998 | Supplement 52Labeling · Standard review | Approved | None posted |
| Jul 3, 1996 | Supplement 51Labeling · Standard review | Approved | None posted |
| Nov 28, 1995 | Supplement 50Manufacturing · Priority review | Approved | None posted |
| Oct 10, 1995 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Jun 9, 1995 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Mar 24, 1995 | Supplement 48Labeling · Standard review | Approved | None posted |
| Mar 13, 1995 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Feb 8, 1995 | Supplement 47Labeling · Standard review | Approved | None posted |
| Jul 29, 1994 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| May 25, 1994 | Supplement 42Labeling · Standard review | Approved | None posted |
| Apr 1, 1993 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Apr 1, 1993 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Jun 9, 1992 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| May 29, 1992 | Supplement 38Labeling | Approved | None posted |
| May 29, 1992 | Supplement 36Labeling | Approved | None posted |
| Dec 31, 1991 | Supplement 27Labeling | Approved | None posted |
| Dec 11, 1991 | Supplement 37Labeling | Approved | None posted |
| Oct 22, 1990 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Oct 22, 1990 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Oct 22, 1990 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Jun 4, 1990 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Dec 19, 1989 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Mar 2, 1989 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Jul 1, 1987 | Supplement 25Labeling | Approved | None posted |
| Jan 28, 1987 | Supplement 22Labeling | Approved | None posted |
| Jan 21, 1987 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Sep 17, 1985 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Jun 28, 1985 | Supplement 18Efficacy (new indication or use) | Approved | None posted |
| Dec 14, 1984 | Supplement 19Labeling | Approved | None posted |
| Dec 14, 1984 | Supplement 10Labeling | Approved | None posted |
| Feb 16, 1984 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Nov 30, 1983 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Aug 26, 1982 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Jul 29, 1982 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Jul 29, 1982 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Jul 29, 1982 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Mar 1, 1982 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Sep 23, 1981 | Supplement 6REMS · Priority review | Approved | None posted |
| Sep 23, 1981 | Supplement 5Labeling | Approved | None posted |
| Jun 11, 1981 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Feb 6, 1981 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Feb 4, 1981 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Feb 7, 1980 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| May 17, 1979 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Feb 27, 1979 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Feb 16, 1979 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Jun 28, 1978 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
