ANDA 91413, held by Natco. Glycopyrrolate.
As of Nov 15, 2026, ANDA 91413 (Glycopyrrolate), held by Natco, was first approved by FDA on Jun 20, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 2016 | Original application | Approved | None posted |
| Glycopyrrolate1MG · tablet;oral | Glycopyrrolate | Rx |
| Glycopyrrolate2MG · tablet;oral | Glycopyrrolate | Rx |
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
