ANDA 204398, held by Rising. Pilocarpine Hydrochloride.
As of Nov 15, 2026, ANDA 204398 (Pilocarpine Hydrochloride), held by Rising, was first approved by FDA on Sep 27, 2017, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2017 | Original application | Approved |
| Pilocarpine Hydrochloride1% · solution/drops;ophthalmic | Pilocarpine Hydrochloride | Rx |
| Pilocarpine Hydrochloride2% · solution/drops;ophthalmic | Pilocarpine Hydrochloride | Rx |
| Pilocarpine Hydrochloride4% · solution/drops;ophthalmic | Pilocarpine Hydrochloride | Rx |
| Mar 24, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 27, 2017 | 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
