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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 217733


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NDA 217733 describes PILOCARPINE HYDROCHLORIDE, which is a drug marketed by Amneal, Fdc Ltd, Rising, Somerset Theraps Llc, Aurobindo Pharma Ltd, Impax Labs, Innogenix, Lannett Co Inc, and Padagis Us, and is included in ten NDAs. It is available from eight suppliers. Additional details are available on the PILOCARPINE HYDROCHLORIDE profile page.

The generic ingredient in PILOCARPINE HYDROCHLORIDE is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
Summary for 217733
Tradename:PILOCARPINE HYDROCHLORIDE
Applicant:Amneal
Ingredient:pilocarpine hydrochloride
Patents:0
Pharmacology for NDA: 217733
Mechanism of ActionCholinergic Agonists
Cholinergic Muscarinic Agonists
Suppliers and Packaging for NDA: 217733
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION/DROPS;OPHTHALMIC 217733 ANDA Amneal Pharmaceuticals NY LLC 60219-2366 60219-2366-2 1 BOTTLE, DROPPER in 1 CARTON (60219-2366-2) / 2.5 mL in 1 BOTTLE, DROPPER
PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION/DROPS;OPHTHALMIC 217733 ANDA Amneal Pharmaceuticals NY LLC 60219-2649 60219-2649-1 1 BOTTLE, DROPPER in 1 CARTON (60219-2649-1) / 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength1.25%
Approval Date:Apr 28, 2025TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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