➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Baxter
Moodys
Colorcon
Express Scripts

Last Updated: October 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207084


Email this page to a colleague

« Back to Dashboard

NDA 207084 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Lannett, Mylan, Pioneer Pharms, Sun Pharm Industries, Watson Labs, West Ward, Akorn, Am Regent, Custopharm Inc, Dr Reddys, Fosun Pharma, Fresenius Kabi Usa, Nexus Pharms, Praxgen, Slate, Alpharma Us Pharms, Generics, Hikma Pharms, Novitium Pharma, and West-ward Pharms Int, and is included in twenty-eight 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 207084
Tradename:DICYCLOMINE HYDROCHLORIDE
Applicant:Akorn
Ingredient:dicyclomine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207084
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 207084
Suppliers and Packaging for NDA: 207084
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride INJECTABLE;INJECTION 207084 ANDA Akorn, Inc. 17478-015 17478-015-02 5 AMPULE in 1 CARTON (17478-015-02) > 2 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:May 4, 2018TE:APRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Medtronic
Express Scripts
McKesson
Colorcon

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 verification 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.