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Last Updated: January 30, 2026

Details for New Drug Application (NDA): 040319


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NDA 040319 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 040319
Tradename:DICYCLOMINE HYDROCHLORIDE
Applicant:Aurobindo Pharma Usa
Ingredient:dicyclomine hydrochloride
Patents:0
Pharmacology for NDA: 040319
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 040319
Muscarinic Antagonists
Parasympatholytics
Suppliers and Packaging for NDA: 040319
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride CAPSULE;ORAL 040319 ANDA Aurobindo Pharma Limited 59651-719 59651-719-01 100 CAPSULE in 1 BOTTLE (59651-719-01)
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride CAPSULE;ORAL 040319 ANDA Aurobindo Pharma Limited 59651-719 59651-719-99 1000 CAPSULE in 1 BOTTLE (59651-719-99)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Sep 7, 1999TE:ABRLD:No

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Preferred Citation:

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