You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 17, 2025

Details for New Drug Application (NDA): 212377

✉ Email this page to a colleague

« Back to Dashboard

NDA 212377 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 212377

Tradename:	PILOCARPINE HYDROCHLORIDE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	pilocarpine hydrochloride
Patents:	0

Pharmacology for NDA: 212377

Mechanism of Action	Cholinergic Agonists Cholinergic Muscarinic Agonists

Suppliers and Packaging for NDA: 212377

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	TABLET;ORAL	212377	ANDA	Aurobindo Pharma Limited	59651-224	59651-224-01	100 TABLET, FILM COATED in 1 BOTTLE (59651-224-01)
PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	TABLET;ORAL	212377	ANDA	Aurobindo Pharma Limited	59651-225	59651-225-01	100 TABLET, FILM COATED in 1 BOTTLE (59651-225-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Aug 13, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Aug 13, 2019	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.