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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089763

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NDA 089763 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 089763
Tradename:THEOPHYLLINE
Applicant:Pliva
Ingredient:theophylline
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 089763
Ingredient-typeXanthines
Suppliers and Packaging for NDA: 089763
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 089763 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1590 N 0615-1590-39
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 089763 ANDA Major Pharmaceuticals 0904-5889 E 0904-5889-61

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Apr 30, 1990TE:ABRLD:No

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