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Argus Health
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Generated: July 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077248

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NDA 077248 describes PILOCARPINE HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Impax Labs, Innogenix, Lannett Co Inc, and Perrigo Pharma Intl, and is included in five 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 are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
Summary for 077248
Applicant:Impax Labs
Ingredient:pilocarpine hydrochloride
Therapeutic Class:Dental and Oral Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077248
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 Impax Generics 0115-5922 N 0115-5922-01
PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 077248 ANDA Impax Generics 0115-5922 N 0115-5922-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 31, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Mar 31, 2006TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
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