Details for New Drug Application (NDA): 077248

NDA 077248 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. Fourteen 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
Formulation / Manufacturing:	see details

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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