NDA 22137, held by Caplin One Labs. Fludarabine Phosphate.
As of Nov 13, 2026, NDA 22137 (Fludarabine Phosphate), held by Caplin One Labs, was first approved by FDA on Sep 21, 2007, with 9 approved supplements and 0 published complete response letters.
| Nov 19, 2024 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Sep 21, 2007 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fludarabine Phosphate50MG/2ML (25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Fludarabine Phosphate | DiscontinuedReference drug |
| Nov 19, 2024 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| May 17, 2016 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| May 10, 2016 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Nov 12, 2015 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Sep 29, 2014 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Mar 25, 2014 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Mar 25, 2014 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Mar 25, 2014 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 18, 2011 | Supplement 3Labeling · Standard review | Approved | |
| Sep 21, 2007 | Original applicationNew formulation or manufacturer · 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
