Treats peptic ulcer. ANDA 90195, held by Velzen Pharma Pvt. Glycopyrrolate.
As of Nov 15, 2026, ANDA 90195 (Glycopyrrolate), held by Velzen Pharma Pvt, was first approved by FDA on Sep 21, 2012, with 1 approved supplement and 0 published complete response letters.
Glycopyrrolate Tablets, USP are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate Tablets, USP are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 21, 2012 | Original application | Approved | None posted |
| Glycopyrrolate1MG · tablet;oral | Glycopyrrolate | Rx |
| Glycopyrrolate2MG · tablet;oral | Glycopyrrolate | Rx |
| Jun 8, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 21, 2012 | 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
