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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Queensland Health
Daiichi Sankyo
Farmers Insurance

Generated: March 20, 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, 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 040086
Applicant:Rhodes Pharms
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040086
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:

Express Scripts
Farmers Insurance
Federal Trade Commission
US Department of Justice

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