BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Deloitte
Boehringer Ingelheim
Mallinckrodt
Dow
Express Scripts
Farmers Insurance
Daiichi Sankyo
McKinsey
Chinese Patent Office
Federal Trade Commission

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087571

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NDA 087571 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-three 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-eight suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 087571
Tradename:THEOPHYLLINE
Applicant:Rhodes Pharms
Ingredient:theophylline
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 087571
Ingredient-typeXanthines
Suppliers and Packaging for NDA: 087571
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 087571 ANDA Rhodes Pharmaceuticals L.P. 42858-701 42858-701-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42858-701-01)
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 087571 ANDA Bryant Ranch Prepack 63629-7169 63629-7169-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7169-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Sep 1, 1982TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Queensland Health
Fuji
Express Scripts
Healthtrust
Citi
Harvard Business School
Fish and Richardson

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