Last Updated: September 24, 2026

Details for New Drug Application (NDA): 076963

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NDA 076963 describes PILOCARPINE HYDROCHLORIDE, which is a drug marketed by Amneal, Fdc Ltd, Rising, Somerset Theraps Llc, Impax Labs, Innogenix, Lannett Co Inc, Padagis Us, and Quagen, and is included in ten NDAs. It is available from seven suppliers. Additional details are available on the PILOCARPINE HYDROCHLORIDE profile page.

The generic ingredient in PILOCARPINE HYDROCHLORIDE is pilocarpine hydrochloride. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.

Summary for 076963

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

Pharmacology for NDA: 076963

Mechanism of Action	Cholinergic Agonists Cholinergic Muscarinic Agonists

Suppliers and Packaging for NDA: 076963

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	TABLET;ORAL	076963	ANDA	AMICI PHARMACEUTICALS LLC	69292-265	69292-265-01	100 TABLET, FILM COATED in 1 BOTTLE (69292-265-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Dec 22, 2004	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Feb 27, 2007	TE:	AB	RLD:	No

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