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Last Updated: October 28, 2021

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Details for New Drug Application (NDA): 207084

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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
Ingredient:dicyclomine hydrochloride
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

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Serving leading biopharmaceutical companies globally:

Express Scripts

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