NDA 19897, held by Population Council. Levonorgestrel.
As of Nov 13, 2026, NDA 19897 (Norplant), held by Population Council, was first approved by FDA on Dec 10, 1990, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 10, 1990 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Norplant36MG/IMPLANT · implant;implantation | Levonorgestrel | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 21, 2001 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Aug 25, 1999 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Dec 11, 1998 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Oct 15, 1997 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Oct 7, 1997 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Sep 15, 1997 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Jul 24, 1996 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Mar 16, 1995 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Jan 31, 1995 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Jan 31, 1995 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Nov 16, 1993 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Dec 10, 1990 | Original applicationNew dosage form · 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
