NDA 11721, held by Lederle. Methazolamide.
As of Nov 15, 2026, NDA 11721 (Neptazane), held by Lederle, was first approved by FDA on Jan 26, 1959, with 9 approved supplements and 0 published complete response letters.
| Nov 25, 1991 | Supplement 15Efficacy (new indication or use) | Approved | None posted |
| Jan 26, 1959 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Neptazane50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Methazolamide | DiscontinuedReference drug |
| Neptazane25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Methazolamide | DiscontinuedReference drug |
| Mar 13, 2009 | Supplement 12Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 18Labeling | Approved | None posted |
| Jan 5, 1999 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Nov 12, 1992 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Nov 25, 1991 | Supplement 15Efficacy (new indication or use) | Approved | None posted |
| Nov 25, 1991 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Nov 25, 1991 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Nov 25, 1991 | Supplement 25Labeling | Approved | None posted |
| Mar 4, 1988 | Supplement 23Labeling | Approved | None posted |
| Jan 26, 1959 | 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
