ANDA 201355, held by Strides Pharma. Nitrofurantoin.
As of Nov 14, 2026, ANDA 201355 (Nitrofurantoin), held by Strides Pharma, was first approved by FDA on Aug 14, 2013, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 14, 2013 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nitrofurantoin25MG/5ML · suspension;oral | Nitrofurantoin | Rx |
| Sep 28, 2016 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 25, 2014 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 14, 2013 | Original application | 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
