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Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 081034

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NDA 081034 describes THEO-24, which is a drug marketed by Actient Pharms, Auxilium Pharms Inc, and Auxilium Pharms Llc, and is included in four NDAs. It is available from two suppliers. Additional details are available on the THEO-24 profile page.

The generic ingredient in THEO-24 is theophylline. There are thirty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 081034
Tradename:THEO-24
Applicant:Auxilium Pharms Inc
Ingredient:theophylline
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 081034
Ingredient-typeXanthines
Suppliers and Packaging for NDA: 081034
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEO-24 theophylline CAPSULE, EXTENDED RELEASE;ORAL 081034 ANDA Endo Pharmaceuticals, Inc. 52244-400 N 52244-400-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Feb 28, 1992TE:RLD:No

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