ANDA 213655, held by Lupin. Glycopyrrolate.
As of Nov 15, 2026, ANDA 213655 (Glycopyrrolate), held by Lupin, was first approved by FDA on Feb 7, 2023, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 7, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Glycopyrrolate0.2MG/ML · injectable;injection | Glycopyrrolate | Discontinued |
| Mar 19, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 7, 2023 | Original application | 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
