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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
UBS
Express Scripts
Deloitte
Chinese Patent Office
Harvard Business School
Daiichi Sankyo
Fish and Richardson
Cantor Fitzgerald

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089807

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NDA 089807 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, Silarx, 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-two 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-seven suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 089807
Tradename:THEOPHYLLINE
Applicant:Pliva
Ingredient:theophylline
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 089807
Ingredient-typeXanthines
Suppliers and Packaging for NDA: 089807
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 089807 ANDA Major Pharmaceuticals 0904-5887 E 0904-5887-61
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 089807 ANDA AvKARE, Inc. 42291-813 N 42291-813-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Apr 30, 1990TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Merck
Julphar
Dow
Covington
Accenture
Mallinckrodt
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