Treats mild to moderate noninfectious allergic and inflammatory disorders of the lid…. NDA 17100, held by Abbvie. Prednisolone Acetate.
As of Nov 13, 2026, NDA 17100 (Pred Mild), held by Abbvie, was first approved by FDA on Nov 10, 1972, with 36 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE PRED MILD is indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 10, 1972 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pred Mild0.12% · suspension/drops;ophthalmic | Prednisolone Acetate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 25, 2025 | Supplement 50Manufacturing | Approved | |
| Dec 8, 2022 | Supplement 46Labeling · Standard review | Approved | None posted |
| Dec 8, 2022 | Supplement 48Labeling · Standard review | Approved | |
| Jun 6, 2018 | Supplement 45Labeling · Standard review | Approved | |
| May 4, 2017 | Supplement 44Labeling · Standard review | Approved | |
| Mar 19, 2003 | Supplement 40Labeling · Standard review | Approved | None posted |
| Apr 12, 2002 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Dec 4, 2001 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Sep 19, 2001 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Apr 12, 2001 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Oct 2, 2000 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| May 8, 1998 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1997 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Dec 5, 1996 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Mar 25, 1996 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Aug 3, 1995 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1993 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1990 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Oct 13, 1989 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Apr 27, 1989 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1988 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Jan 27, 1988 | Supplement 21Labeling | Approved | None posted |
| Oct 29, 1987 | Supplement 22Labeling | Approved | None posted |
| Jul 8, 1986 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1986 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 2, 1982 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Sep 2, 1982 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Aug 13, 1982 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Sep 4, 1980 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jan 29, 1980 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Oct 2, 1979 | Supplement 9Labeling | Approved | None posted |
| Feb 28, 1977 | Supplement 3Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 8Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 7Labeling | Approved | None posted |
| Feb 23, 1977 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Feb 23, 1977 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Nov 10, 1972 | Original applicationNew dosage form · 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
