NDA 20992, held by Aspen. Estrogens, Conjugated Synthetic A.
As of Nov 13, 2026, NDA 20992 (Cenestin), held by Aspen, was first approved by FDA on Mar 24, 1999, with 29 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 5, 2004 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Jun 21, 2002 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Mar 24, 1999 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cenestin0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Estrogens, Conjugated Synthetic A | DiscontinuedReference drug |
| Cenestin0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Estrogens, Conjugated Synthetic A | DiscontinuedReference drug |
| Cenestin0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Estrogens, Conjugated Synthetic A | DiscontinuedReference drug |
| Cenestin1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Estrogens, Conjugated Synthetic A | DiscontinuedReference drug |
| Cenestin0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Estrogens, Conjugated Synthetic A | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 12, 2026 | Supplement 43Labeling · Standard review | Approved | |
| Feb 15, 2024 | Supplement 41Labeling · Standard review | Approved | |
| Nov 30, 2020 | Supplement 38Labeling · Standard review | Approved | |
| Nov 30, 2020 | Supplement 39Labeling · Standard review | Approved | |
| Nov 1, 2017 | Supplement 37Labeling · Standard review | Approved | |
| Mar 20, 2015 | Supplement 34Labeling | Approved | |
| Oct 28, 2004 | Supplement 26Labeling · Standard review | Approved | |
| Feb 5, 2004 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Jan 28, 2004 | Supplement 24Labeling · Standard review | Approved | |
| Nov 5, 2002 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Oct 18, 2002 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jun 21, 2002 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Apr 29, 2002 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Mar 5, 2002 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Feb 22, 2002 | Supplement 11Labeling · Standard review | Approved | |
| Feb 8, 2002 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Feb 8, 2002 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 10, 2001 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Sep 5, 2001 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Sep 5, 2001 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jul 20, 2001 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Aug 9, 2000 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Mar 13, 2000 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jan 27, 2000 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jan 7, 2000 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Nov 12, 1999 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1999 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Nov 2, 1999 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Sep 7, 1999 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 24, 1999 | Original applicationNew dosage form · Standard review | Approved |
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