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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Mallinckrodt
Moodys
McKesson
Boehringer Ingelheim
AstraZeneca
Novartis
Baxter
Johnson and Johnson
Accenture

Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085082

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NDA 085082 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Sun Pharm Inds, Hikma Pharms Llc, 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-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. Forty-three suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.

Summary for NDA: 085082

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

Pharmacology for NDA: 085082

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 085082

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICYCLOMINE HYDROCHLORIDE
dicyclomine hydrochloride
CAPSULE;ORAL 085082 ANDA Actavis Pharma, Inc. 0591-0794 0591-0794-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0794-01)
DICYCLOMINE HYDROCHLORIDE
dicyclomine hydrochloride
CAPSULE;ORAL 085082 ANDA Actavis Pharma, Inc. 0591-0794 0591-0794-10 1000 CAPSULE in 1 BOTTLE, PLASTIC (0591-0794-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Jun 19, 1986TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Julphar
Cipla
Express Scripts
Baxter
McKinsey
QuintilesIMS
Covington
McKesson
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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