BLA 17016, held by Ferring. Gonadotropin, Chorionic.
As of Nov 13, 2026, BLA 17016 (Chorionic Gonadotropin), held by Ferring, was first approved by FDA on Jan 15, 1974, with 87 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. Prepubertal cryptorchidism not due to anatomic obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to predict whether or not orchiopexy will be needed in the future.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 15, 1974 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Chorionic Gonadotropin20,000 UNITS/VIAL · injectable;injection | Gonadotropin, Chorionic | Discontinued |
| Chorionic Gonadotropin5,000 UNITS/VIAL · injectable;injection | Gonadotropin, Chorionic | Rx |
| Chorionic Gonadotropin10,000 UNITS/VIAL · injectable;injection | Gonadotropin, Chorionic | Rx |
| Chorionic Gonadotropin2,000 UNITS/VIAL · injectable;injection | Gonadotropin, Chorionic | Discontinued |
| Chorionic Gonadotropin15,000 UNITS/VIAL · injectable;injection | Gonadotropin, Chorionic | Discontinued |
| Chorionic Gonadotropin2,000 UNITS/VIAL · injectable;injection | Gonadotropin, Chorionic | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 23, 2023 | Supplement 172Labeling · Standard review | Approved | |
| Jan 9, 2017 | Supplement 163Manufacturing · Standard review | Approved | None posted |
| Mar 7, 2016 | Supplement 160Manufacturing · Standard review | Approved | None posted |
| Oct 21, 2015 | Supplement 159Manufacturing · Standard review | Approved | None posted |
| May 2, 2014 | Supplement 158Manufacturing · Standard review | Approved | None posted |
| Apr 15, 2011 | Supplement 156Labeling | Approved | |
| Jun 10, 2008 | Supplement 155Manufacturing | Approved | None posted |
| Oct 21, 2002 | Supplement 150Labeling · Standard review | Approved | None posted |
| Jan 13, 1999 | Supplement 148Manufacturing · Standard review | Approved | None posted |
| Aug 21, 1998 | Supplement 147Manufacturing · Standard review | Approved | None posted |
| Apr 15, 1998 | Supplement 146Manufacturing · Standard review | Approved | None posted |
| Apr 7, 1997 | Supplement 145Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1996 | Supplement 143Manufacturing · Standard review | Approved | None posted |
| Nov 18, 1996 | Supplement 144Manufacturing · Standard review | Approved | None posted |
| Mar 22, 1994 | Supplement 141Manufacturing · Standard review | Approved | None posted |
| May 28, 1993 | Supplement 142Labeling · Standard review | Approved | None posted |
| Feb 11, 1993 | Supplement 140Labeling · Standard review | Approved | None posted |
| Sep 23, 1991 | Supplement 138Labeling | Approved | None posted |
| Sep 5, 1991 | Supplement 139Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1990 | Supplement 136Manufacturing · Standard review | Approved | None posted |
| Feb 6, 1990 | Supplement 137Labeling | Approved | None posted |
| Dec 28, 1988 | Supplement 135Manufacturing · Standard review | Approved | None posted |
| Jan 5, 1988 | Supplement 134Labeling | Approved | None posted |
| May 12, 1986 | Supplement 133Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1985 | Supplement 131Manufacturing · Standard review | Approved | None posted |
| Dec 27, 1984 | Supplement 132Manufacturing · Standard review | Approved | None posted |
| Sep 18, 1984 | Supplement 130Manufacturing · Standard review | Approved | None posted |
| Oct 20, 1982 | Supplement 126Labeling | Approved | None posted |
| Jun 10, 1982 | Supplement 127Labeling | Approved | None posted |
| Jun 24, 1981 | Supplement 121Manufacturing · Standard review | Approved | None posted |
| Apr 15, 1981 | Supplement 123Manufacturing · Standard review | Approved | None posted |
| Jan 5, 1981 | Supplement 113Labeling | Approved | None posted |
| Jan 5, 1981 | Supplement 116Labeling | Approved | None posted |
| Nov 7, 1980 | Supplement 108Manufacturing · Standard review | Approved | None posted |
| Mar 11, 1980 | Supplement 100Labeling | Approved | None posted |
| Mar 11, 1980 | Supplement 101Labeling | Approved | None posted |
| Mar 11, 1980 | Supplement 102Labeling | Approved | None posted |
| Mar 11, 1980 | Supplement 103Labeling | Approved | None posted |
| Mar 11, 1980 | Supplement 104Labeling | Approved | None posted |
| Mar 11, 1980 | Supplement 105Labeling | Approved | None posted |
| Mar 11, 1980 | Supplement 106Labeling | Approved | None posted |
| Mar 11, 1980 | Supplement 107Labeling | Approved | None posted |
| Oct 3, 1979 | Supplement 70Labeling | Approved | None posted |
| Oct 3, 1979 | Supplement 71Labeling | Approved | None posted |
| Oct 3, 1979 | Supplement 72Labeling | Approved | None posted |
| Oct 3, 1979 | Supplement 73Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 98Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 99Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 74Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 75Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 76Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 77Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 78Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 79Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 80Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 81Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 82Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 83Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 84Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 85Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 86Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 87Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 88Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 89Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 90Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 91Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 93Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 94Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 95Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 96Labeling | Approved | None posted |
| Oct 2, 1979 | Supplement 97Labeling | Approved | None posted |
| Mar 19, 1979 | Supplement 68Labeling | Approved | None posted |
| Jan 2, 1979 | Supplement 67Labeling | Approved | None posted |
| Dec 13, 1978 | Supplement 65Labeling | Approved | None posted |
| Sep 21, 1978 | Supplement 66Labeling | Approved | None posted |
| May 25, 1978 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Apr 20, 1976 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Apr 20, 1976 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Apr 20, 1976 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Apr 20, 1976 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Jan 16, 1976 | Supplement 57Labeling | Approved | None posted |
| Jan 16, 1976 | Supplement 58Labeling | Approved | None posted |
| Jan 15, 1976 | Supplement 54Labeling | Approved | None posted |
| Jan 15, 1976 | Supplement 56Labeling | Approved | None posted |
| Jun 26, 1975 | Supplement 1Labeling | Approved | None posted |
| Jun 10, 1975 | Supplement 50Labeling | Approved | None posted |
| Jan 16, 1975 | Supplement 55Labeling | Approved | None posted |
| Jan 15, 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 weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
