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Julphar
Baxter
Farmers Insurance
Moodys
Merck
Boehringer Ingelheim
Healthtrust
Fuji
Queensland Health

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091586

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NDA 091586 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 091586
Tradename:THEOPHYLLINE
Applicant:Tris Pharma Inc
Ingredient:theophylline
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091586
Ingredient-typeXanthines
Suppliers and Packaging for NDA: 091586
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE theophylline SOLUTION;ORAL 091586 ANDA Tris Pharma Inc 27808-033 N 27808-033-01
THEOPHYLLINE theophylline SOLUTION;ORAL 091586 ANDA Cranbury Pharmaceuticals Inc 60621-033 N 60621-033-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength80MG/15ML
Approval Date:Jun 15, 2012TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
Cerilliant
QuintilesIMS
Julphar
Covington
Citi
AstraZeneca
Cantor Fitzgerald

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