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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 204398

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NDA 204398 describes PILOCARPINE HYDROCHLORIDE, which is a drug marketed by Amneal, Rising, Somerset Theraps Llc, Aurobindo Pharma Ltd, Impax Labs, Innogenix, Lannett Co Inc, and Padagis Us, and is included in eight NDAs. It is available from nine 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. Fifteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.

Summary for 204398

Tradename:	PILOCARPINE HYDROCHLORIDE
Applicant:	Rising
Ingredient:	pilocarpine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;OPHTHALMIC			Strength	1%
Approval Date:	Sep 27, 2017	TE:	AT	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;OPHTHALMIC			Strength	2%
Approval Date:	Sep 27, 2017	TE:	AT	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;OPHTHALMIC			Strength	4%
Approval Date:	Sep 27, 2017	TE:	AT	RLD:	No

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