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Generated: May 27, 2019

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Details for New Drug Application (NDA): 087944

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NDA 087944 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 one supplier. 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-two suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 087944
Applicant:Auxilium Pharms Llc
Formulation / Manufacturing:see details
Pharmacology for NDA: 087944
Suppliers and Packaging for NDA: 087944
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEO-24 theophylline CAPSULE, EXTENDED RELEASE;ORAL 087944 ANDA Endo Pharmaceuticals, Inc. 52244-300 52244-300-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-300-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Aug 22, 1983TE:RLD:No

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