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Last Updated: August 5, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084285

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NDA 084285 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Lannett, Mylan, Pioneer Pharms, Sun Pharm Industries, Watson Labs, West Ward, Akorn Inc, Am Regent, Custopharm Inc, Dr Reddys, Fosun Pharma, Fresenius Kabi Usa, Nexus Pharms, Slate, Sungen Pharma, Alpharma Us Pharms, Generics, Hikma, Hikma Pharms, and West-ward Pharms Int, and is included in twenty-seven NDAs. It is available from thirty-eight suppliers. Additional details are available on the DICYCLOMINE HYDROCHLORIDE profile page.

The generic ingredient in DICYCLOMINE HYDROCHLORIDE is dicyclomine hydrochloride. There are four drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 084285
Tradename:DICYCLOMINE HYDROCHLORIDE
Applicant:Lannett
Ingredient:dicyclomine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 084285
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 084285
Suppliers and Packaging for NDA: 084285
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride CAPSULE;ORAL 084285 ANDA Lannett Company, Inc. 0527-0586 0527-0586-01 100 CAPSULE in 1 BOTTLE (0527-0586-01)
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride CAPSULE;ORAL 084285 ANDA Lannett Company, Inc. 0527-0586 0527-0586-05 500 CAPSULE in 1 BOTTLE (0527-0586-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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Harvard Business School
Colorcon

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