Reduces elevated intraocular pressure (IOP). ANDA 210384, held by Somerset Theraps LLC. Pilocarpine Hydrochloride.
As of Nov 15, 2026, ANDA 210384 (Pilocarpine Hydrochloride), held by Somerset Theraps LLC, was first approved by FDA on Nov 25, 2019, with 0 approved supplements and 0 published complete response letters.
Pilocarpine hydrochloride ophthalmic solution, is indicated for the: Pilocarpine hydrochloride ophthalmic solution, USP is a muscarinic cholinergic agonist indicated for The reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension The management of acute angle-closure glaucoma The prevention of postoperative elevated IOP associated with laser surgery The induction of miosis 1.1 Reduction of Elevated Intraocular Pressure (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension 1.2 Management of Acute Angle-Closure Glaucoma 1.3 Prevention of Postoperative Elevated IOP Associated with Laser Surgery 1.4 Induction of Miosis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 25, 2019 | Original application | Approved | None posted |
| Pilocarpine Hydrochloride1% · solution/drops;ophthalmic | Pilocarpine Hydrochloride | Rx |
| Pilocarpine Hydrochloride2% · solution/drops;ophthalmic | Pilocarpine Hydrochloride | Rx |
| Pilocarpine Hydrochloride4% · solution/drops;ophthalmic | Pilocarpine Hydrochloride | 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
