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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 217054


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NDA 217054 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Usa, Corepharma, Lannett, Pioneer Pharms, Prinston Inc, Rising, Sun Pharm Industries, Twi Pharms, Watson Labs, West Ward, Am Regent, Dr Reddys, Fosun Pharma, Fresenius Kabi Usa, Hikma, Nexus, Praxgen Pharms, Renew Pharms, Slate Run Pharma, Somerset Theraps Llc, Alpharma Us Pharms, Novitium Pharma, Ph Health, Bionpharma, Hikma Pharms, and Rubicon Research, and is included in forty-two NDAs. It is available from forty-six 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-six suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 217054
Tradename:DICYCLOMINE HYDROCHLORIDE
Applicant:Twi Pharms
Ingredient:dicyclomine hydrochloride
Patents:0
Pharmacology for NDA: 217054
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 217054
Muscarinic Antagonists
Parasympatholytics
Suppliers and Packaging for NDA: 217054
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride CAPSULE;ORAL 217054 ANDA Upsher-Smith Laboratories, LLC 24979-201 24979-201-01 100 CAPSULE in 1 BOTTLE (24979-201-01)
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride CAPSULE;ORAL 217054 ANDA Upsher-Smith Laboratories, LLC 24979-201 24979-201-03 1000 CAPSULE in 1 BOTTLE (24979-201-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Dec 27, 2022TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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