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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Express Scripts
Argus Health

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 012462

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NDA 012462 describes LOMOTIL, which is a drug marketed by Gd Searle Llc and is included in two NDAs. It is available from nine suppliers. Additional details are available on the LOMOTIL profile page.

The generic ingredient in LOMOTIL is atropine sulfate; diphenoxylate hydrochloride. There are twenty-three drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.
Summary for 012462
Applicant:Gd Searle Llc
Ingredient:atropine sulfate; diphenoxylate hydrochloride
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 012462
Suppliers and Packaging for NDA: 012462
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOMOTIL atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 012462 NDA G.D. Searle LLC Division of Pfizer Inc 0025-0061 N 0025-0061-31
LOMOTIL atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 012462 NDA AUTHORIZED GENERIC Atlantic Biologicals Corps 17856-1061 N 17856-1061-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.025MG;2.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Daiichi Sankyo
Federal Trade Commission
Queensland Health

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