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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 216736


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NDA 216736 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Usa, Corepharma, Lannett, Pioneer Pharms, Prinston Inc, 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, Alpharma Us Pharms, Endo Operations, Novitium Pharma, Bionpharma, Hikma Pharms, and Rubicon, and is included in thirty-seven NDAs. It is available from fifty-three 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. Fifty-four suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 216736
Tradename:DICYCLOMINE HYDROCHLORIDE
Applicant:Rubicon
Ingredient:dicyclomine hydrochloride
Patents:0
Pharmacology for NDA: 216736
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 216736
Suppliers and Packaging for NDA: 216736
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride TABLET;ORAL 216736 ANDA Northwind Pharmaceuticals, LLC 51655-548 51655-548-26 90 TABLET in 1 BOTTLE, PLASTIC (51655-548-26)
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride TABLET;ORAL 216736 ANDA Northwind Pharmaceuticals, LLC 51655-548 51655-548-52 30 TABLET in 1 BOTTLE, PLASTIC (51655-548-52)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Dec 14, 2022TE:ABRLD:No

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