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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Queensland Health
Mallinckrodt
US Department of Justice
Fish and Richardson
Cerilliant
Cipla
Julphar
Federal Trade Commission
AstraZeneca

Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086727

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NDA 086727 describes DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, which is a drug marketed by Sun Pharm Inds, West-ward Pharms Int, Inwood Labs, Ani Pharms Inc, Parke Davis, Ascot, R And S Pharma, Usl Pharma, Lederle, Par Pharm, Roxane, Kv Pharm, Mylan, Hikma Pharms, Pvt Form, Lannett, Sandoz, Watson Labs, Able, Valeant Pharm Intl, and Heather, and is included in twenty-one NDAs. It is available from twenty-six suppliers. Additional details are available on the DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE profile page.

The generic ingredient in DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE is atropine sulfate; diphenoxylate hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.

Summary for NDA: 086727

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

Pharmacology for NDA: 086727

Mechanism of ActionCholinergic Antagonists
Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 086727

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
atropine sulfate; diphenoxylate hydrochloride
 TABLET;ORAL 086727 ANDA Stat Rx USA 16590-080 16590-080-30 30 TABLET in 1 BOTTLE (16590-080-30)
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
atropine sulfate; diphenoxylate hydrochloride
 TABLET;ORAL 086727 ANDA ANI Pharmaceuticals, Inc. 62559-490 62559-490-01 100 TABLET in 1 BOTTLE (62559-490-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.025MG;2.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

Accenture
Fish and Richardson
Merck
Medtronic
Chubb
McKesson
Colorcon
Julphar
Johnson and Johnson
Queensland Health

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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