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Last Updated: October 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210257

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NDA 210257 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Lannett, Mylan, Pioneer Pharms, Sun Pharm Industries, Watson Labs, West Ward, Akorn Inc, Am Regent, Apc Pharms Llc, Custopharm Inc, Dr Reddys, Fresenius Kabi Usa, Nexus Pharms, Slate, Sungen Pharma, Alpharma Us Pharms, Generics, Hikma Pharms, and West-ward Pharms Int, and is included in twenty-six NDAs. It is available from forty-two 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-four suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 210257
Tradename:DICYCLOMINE HYDROCHLORIDE
Applicant:Fresenius Kabi Usa
Ingredient:dicyclomine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210257
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 210257
Suppliers and Packaging for NDA: 210257
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride INJECTABLE;INJECTION 210257 ANDA Fresenius Kabi USA, LLC 63323-842 63323-842-02 5 VIAL, SINGLE-DOSE in 1 CARTON (63323-842-02) > 2 mL in 1 VIAL, SINGLE-DOSE (63323-842-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jan 25, 2019TE:APRLD:No

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