NDA 9388, held by Teva Womens. Acetazolamide Sodium.
As of Nov 14, 2026, NDA 9388 (Diamox), held by Teva Womens, was first approved by FDA on Jun 25, 1954, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 25, 1954 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| DiamoxEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Acetazolamide Sodium | DiscontinuedReference drug |
| Sep 20, 2024 | Supplement 39Labeling · Standard review | Approved | |
| May 13, 2022 | Supplement 38Labeling · Standard review | Approved | |
| Nov 26, 2002 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Sep 6, 2000 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1999 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Jul 1, 1994 | Supplement 30Labeling · Standard review | Approved | None posted |
| Jul 1, 1994 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Dec 9, 1993 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Dec 13, 1990 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Dec 5, 1990 | Supplement 25Labeling | Approved | None posted |
| Jun 25, 1954 | 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
