Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts

Last Updated: October 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210257

See Plans and Pricing

« Back to Dashboard

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
Applicant:Fresenius Kabi Usa
Ingredient:dicyclomine hydrochloride
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.