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Generated: December 11, 2018

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Details for New Drug Application (NDA): 077220

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NDA 077220 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 077220
Applicant:Lannett Co Inc
Ingredient:pilocarpine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 077220
Suppliers and Packaging for NDA: 077220
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 077220 ANDA KAISER FOUNDATION HOSPITALS 0179-0153 0179-0153-70 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0179-0153-70)
PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 077220 ANDA Lannett Company, Inc. 0527-1313 0527-1313-01 100 TABLET, FILM COATED in 1 BOTTLE (0527-1313-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 14, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:May 6, 2009TE:ABRLD:No

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