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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 040230


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NDA 040230 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by 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, Generics, Novitium Pharma, Bionpharma, Hikma Pharms, and Rubicon, and is included in thirty-five NDAs. It is available from fifty-one 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-two suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.
Summary for 040230
Tradename:DICYCLOMINE HYDROCHLORIDE
Applicant:Lannett
Ingredient:dicyclomine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040230
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 040230
Suppliers and Packaging for NDA: 040230
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride TABLET;ORAL 040230 ANDA Lannett Company, Inc. 0527-1282 0527-1282-01 100 TABLET in 1 BOTTLE (0527-1282-01)
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride TABLET;ORAL 040230 ANDA Lannett Company, Inc. 0527-1282 0527-1282-05 500 TABLET in 1 BOTTLE (0527-1282-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Feb 26, 1999TE:ABRLD:No

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