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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 061454

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NDA 061454 describes DICLOXACILLIN SODIUM, which is a drug marketed by Sandoz, Teva, and Apothecon, and is included in three NDAs. It is available from fourteen suppliers. Additional details are available on the DICLOXACILLIN SODIUM profile page.

The generic ingredient in DICLOXACILLIN SODIUM is dicloxacillin sodium. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dicloxacillin sodium profile page.
Summary for 061454
Tradename:DICLOXACILLIN SODIUM
Applicant:Sandoz
Ingredient:dicloxacillin sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 061454
Ingredient-typePenicillins
Medical Subject Heading (MeSH) Categories for 061454
Suppliers and Packaging for NDA: 061454
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOXACILLIN SODIUM dicloxacillin sodium CAPSULE;ORAL 061454 ANDA Liberty Pharmaceuticals, Inc. 0440-1380 N 0440-1380-40
DICLOXACILLIN SODIUM dicloxacillin sodium CAPSULE;ORAL 061454 ANDA Sandoz Inc 0781-2248 N 0781-2248-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 250MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 125MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Teva
Harvard Business School
Johnson and Johnson
Deloitte
QuintilesIMS
Argus Health
Boehringer Ingelheim
Dow

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