Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212058

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NDA 212058 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Lannett, Mylan, Pioneer Pharms, Sun Pharm Industries, Watson Labs, West Ward, Akorn Inc, Am Regent, Custopharm Inc, Dr Reddys, Fosun Pharma, Fresenius Kabi Usa, Nexus Pharms, Slate, Sungen Pharma, Alpharma Us Pharms, Generics, Hikma Pharms, and West-ward Pharms Int, and is included in twenty-six NDAs. It is available from forty-four 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 212058
Tradename:DICYCLOMINE HYDROCHLORIDE
Applicant:Sungen Pharma
Ingredient:dicyclomine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212058
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 212058
Suppliers and Packaging for NDA: 212058
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride INJECTABLE;INJECTION 212058 ANDA Camber Pharmaceuticals, Inc. 31722-963 31722-963-32 5 VIAL in 1 BOX (31722-963-32) > 2 mL in 1 VIAL (31722-963-31)
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride INJECTABLE;INJECTION 212058 ANDA SunGen Pharma LLC 70625-103 70625-103-05 5 VIAL in 1 BOX (70625-103-05) > 2 mL in 1 VIAL (70625-103-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Apr 26, 2019TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
Medtronic

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