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Details for New Drug Application (NDA): 085509

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NDA 085509 describes DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, which is a drug marketed by Sun Pharm Inds, Roxane, Inwood Labs, Ani Pharms Inc, Parke Davis, Ascot, R And S Pharma, Usl Pharma, Lederle, Par Pharm, Kv Pharm, Mylan, Hikma Pharms Llc, Pvt Form, Lannett, Sandoz, Watson Labs, Able, Valeant Pharm Intl, and Heather, and is included in twenty-one NDAs. It is available from twenty-four 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 drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.

Summary for NDA: 085509

Tradename:
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Applicant:
Inwood Labs
Ingredient:
atropine sulfate; diphenoxylate hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Summary for product number 001

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


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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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