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McKesson
Queensland Health
UBS
US Department of Justice
QuintilesIMS
Daiichi Sankyo
Johnson and Johnson
US Army
Dow

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040086

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NDA 040086 describes THEOPHYLLINE, which is a drug marketed by Cent Pharms, Hospira, Inwood Labs, Sandoz, Kv Pharm, Scherer Rp, Alpharma Us Pharms, Cenci, Chartwell Rx, Halsey, Pharm Assoc, Precision Dose, Roxane, Taro, Wockhardt, Lannett Co Inc, Tris Pharma Inc, Able, Alembic Pharms Ltd, Glenmark Generics, Mylan Ireland Ltd, Pliva, Rhodes Pharms, Teva Pharms, B Braun, Baxter Hlthcare, and Hospira Inc, and is included in forty-four NDAs. It is available from twenty-one suppliers. Additional details are available on the THEOPHYLLINE profile page.

The generic ingredient in THEOPHYLLINE 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 040086
Tradename:THEOPHYLLINE
Applicant:Rhodes Pharms
Ingredient:theophylline
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040086
Ingredient-typeXanthines
Suppliers and Packaging for NDA: 040086
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 040086 ANDA Rhodes Pharmaceuticals L.P. 42858-702 N 42858-702-01
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 040086 ANDA Purdue Pharmaceutical Products LP 67781-252 E 67781-252-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Apr 15, 1996TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
QuintilesIMS
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Chubb
Chinese Patent Office
Argus Health
Colorcon
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Mallinckrodt

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