NDA 21726, held by Ucb Inc. Alprazolam.
As of Nov 14, 2026, NDA 21726 (Niravam), held by Ucb Inc, was first approved by FDA on Jan 19, 2005, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 19, 2005 | Original applicationNew dosage form · Standard review | Approved |
| Niravam0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Alprazolam | DiscontinuedReference drug |
| Niravam0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Alprazolam | DiscontinuedReference drug |
| Niravam1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Alprazolam | DiscontinuedReference drug |
| Niravam2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Alprazolam | DiscontinuedReference drug |
| Dec 14, 2012 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jun 16, 2011 | Supplement 8Labeling · Standard review | Approved | |
| Feb 6, 2006 | Supplement 6Manufacturing | Approved | |
| Jan 19, 2005 | 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
