Last Updated: September 24, 2026

Details for New Drug Application (NDA): 077248

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NDA 077248 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 077248

Tradename:	PILOCARPINE HYDROCHLORIDE
Applicant:	Impax Labs
Ingredient:	pilocarpine hydrochloride
Patents:	0

Pharmacology for NDA: 077248

Mechanism of Action	Cholinergic Agonists Cholinergic Muscarinic Agonists

Suppliers and Packaging for NDA: 077248

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PILOCARPINE HYDROCHLORIDE	pilocarpine hydrochloride	TABLET;ORAL	077248	ANDA	Amneal Pharmaceuticals NY LLC	60219-5922	60219-5922-1	100 TABLET, FILM COATED in 1 BOTTLE (60219-5922-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 31, 2006	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Mar 31, 2006	TE:	AB	RLD:	No

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