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Serving leading biopharmaceutical companies globally:

Accenture
Fish and Richardson
Teva
Fuji
AstraZeneca
Chinese Patent Office
McKinsey
US Army
Julphar
Johnson and Johnson

Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040319

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NDA 040319 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Sun Pharm Inds, Hikma Pharms, Watson Labs, Mylan, Lannett, Luitpold Pharms Inc, Pioneer Pharms, Mikart, Alpharma Us Pharms, and West-ward Pharms Int, and is included in nineteen NDAs. It is available from forty-five 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-seven suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.

Summary for NDA: 040319

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040319

Mechanism of ActionCholinergic Antagonists

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 Mylan Pharmaceuticals Inc. 0378-1610 0378-1610-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1610-01)
DICYCLOMINE HYDROCHLORIDE
dicyclomine hydrochloride
CAPSULE;ORAL 040319 ANDA Mylan Pharmaceuticals Inc. 0378-1610 0378-1610-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1610-05)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Fuji
Novartis
Queensland Health
Harvard Business School
Healthtrust
AstraZeneca
Boehringer Ingelheim
Express Scripts
Daiichi Sankyo
Moodys

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