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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089808

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NDA 089808 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-four 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-nine suppliers are listed for this compound. Additional details are available on the theophylline profile page.

Summary for 089808

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 089808

Ingredient-typeXanthines

Suppliers and Packaging for NDA: 089808

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 089808 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2503 0615-2503-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-2503-39)
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 089808 ANDA Major Pharmaceuticals 0904-5888 0904-5888-61 100 TABLET, EXTENDED RELEASE in 1 BOX, UNIT-DOSE (0904-5888-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Apr 30, 1990TE:ABRLD:No


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