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Serving 500+ biopharmaceutical companies globally:

UBS
Queensland Health
Daiichi Sankyo
McKinsey
Boehringer Ingelheim
Fuji
Fish and Richardson
QuintilesIMS
Chinese Patent Office
Johnson and Johnson

Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 008370

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NDA 008370 describes BENTYL PRESERVATIVE FREE, which is a drug marketed by Forest Labs Inc and is included in one NDA. It is available from one supplier. Additional details are available on the BENTYL PRESERVATIVE FREE profile page.

The generic ingredient in BENTYL PRESERVATIVE FREE 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: 008370

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 008370

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 008370

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENTYL
dicyclomine hydrochloride
INJECTABLE;INJECTION 008370 NDA Aptalis Pharma US, Inc. 58914-080 58914-080-52 5 AMPULE in 1 BOX (58914-080-52) > 2 mL in 1 AMPULE
BENTYL PRESERVATIVE FREE
dicyclomine hydrochloride
INJECTABLE;INJECTION 008370 NDA Aptalis Pharma US, Inc. 58914-080 58914-080-52 5 AMPULE in 1 BOX (58914-080-52) > 2 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Oct 15, 1984TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Oct 15, 1984TE:APRLD:Yes


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Serving 500+ biopharmaceutical companies globally:

US Army
Covington
Cerilliant
Cipla
Farmers Insurance
Johnson and Johnson
Fish and Richardson
US Department of Justice
Chubb
McKesson

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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