NDA 17439, held by Allergan. Hydroxyprogesterone Caproate.
As of Nov 13, 2026, NDA 17439 (Hydroxyprogesterone Caproate), held by Allergan, was first approved by FDA on Dec 26, 1974, with 75 approved supplements and 0 published complete response letters.
| Mar 23, 1981 | Supplement 102Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1981 | Supplement 104Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1981 | Supplement 105Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1981 | Supplement 106Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1981 | Supplement 107Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1981 | Supplement 108Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1981 | Supplement 109Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 82Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 84Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 89Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 91Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 92Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 97Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 101Efficacy (new indication or use) | Approved | None posted |
| Dec 26, 1974 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Hydroxyprogesterone Caproate125MG/ML · injectable;injection | Hydroxyprogesterone Caproate | Discontinued |
| Hydroxyprogesterone Caproate250MG/ML · injectable;injection | Hydroxyprogesterone Caproate | Discontinued |
| Jan 19, 1999 | Supplement 124Manufacturing · Standard review | Approved | None posted |
| Oct 15, 1998 | Supplement 123Manufacturing · Standard review | Approved | None posted |
| Feb 4, 1997 | Supplement 122Manufacturing · Standard review | Approved | None posted |
| May 14, 1991 | Supplement 113Labeling | Approved | None posted |
| May 14, 1991 | Supplement 118Labeling | Approved | None posted |
| May 14, 1991 | Supplement 119Labeling | Approved | None posted |
| Feb 19, 1991 | Supplement 120Labeling | Approved | None posted |
| Jan 3, 1990 | Supplement 116Manufacturing · Standard review | Approved | None posted |
| Jun 12, 1989 | Supplement 117Manufacturing · Standard review | Approved | None posted |
| Dec 14, 1988 | Supplement 115Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1988 | Supplement 114Manufacturing · Standard review | Approved | None posted |
| May 12, 1986 | Supplement 112Manufacturing · Standard review | Approved | None posted |
| Mar 27, 1985 | Supplement 111Labeling | Approved | None posted |
| Mar 23, 1981 | Supplement 99Labeling | Approved | None posted |
| Mar 23, 1981 | Supplement 102Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1981 | Supplement 104Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1981 | Supplement 105Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1981 | Supplement 106Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1981 | Supplement 107Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1981 | Supplement 108Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1981 | Supplement 109Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 73Labeling | Approved | None posted |
| Jan 23, 1980 | Supplement 74Labeling | Approved | None posted |
| Jan 23, 1980 | Supplement 76Labeling | Approved | None posted |
| Jan 23, 1980 | Supplement 78Labeling | Approved | None posted |
| Jan 23, 1980 | Supplement 79Labeling | Approved | None posted |
| Jan 23, 1980 | Supplement 80Labeling | Approved | None posted |
| Jan 23, 1980 | Supplement 82Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 84Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 89Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 91Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 92Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 95Manufacturing · Standard review | Approved | None posted |
| Jan 23, 1980 | Supplement 96Labeling | Approved | None posted |
| Jan 23, 1980 | Supplement 97Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 98Labeling | Approved | None posted |
| Jan 23, 1980 | Supplement 100Labeling | Approved | None posted |
| Jan 23, 1980 | Supplement 101Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1980 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jan 23, 1980 | Supplement 67Labeling | Approved | None posted |
| Jan 23, 1980 | Supplement 68Labeling | Approved | None posted |
| Jan 23, 1980 | Supplement 69Labeling | Approved | None posted |
| Jan 23, 1980 | Supplement 70Labeling | Approved | None posted |
| Jan 23, 1980 | Supplement 71Labeling | Approved | None posted |
| Jan 23, 1980 | Supplement 72Labeling | Approved | None posted |
| Dec 7, 1977 | Supplement 16Labeling | Approved | None posted |
| Dec 7, 1977 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1977 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Jul 20, 1976 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| May 3, 1976 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 3, 1976 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 3, 1976 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| May 3, 1976 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1976 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1976 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1976 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Oct 3, 1975 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 26, 1974 | Original applicationNew formulation or manufacturer · Standard 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
