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Serving leading biopharmaceutical companies globally:

Express Scripts
US Army

Generated: December 16, 2017

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 ten suppliers. Additional details are available on the LOMOTIL profile page.

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

Summary for 012462

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 0025-0061-31 100 TABLET in 1 BOTTLE (0025-0061-31)
LOMOTIL atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 012462 NDA AUTHORIZED GENERIC Atlantic Biologicals Corps 17856-1061 17856-1061-1 100 DOSE PACK in 1 CONTAINER (17856-1061-1) > 1 TABLET in 1 DOSE PACK

Summary 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 leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
US Department of Justice
Argus Health
Express Scripts

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