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Serving leading biopharmaceutical companies globally:

Accenture
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Merck
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Healthtrust
Covington
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Farmers Insurance
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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040560

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NDA 040560 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 040560
Tradename:THEOPHYLLINE
Applicant:Mylan Ireland Ltd
Ingredient:theophylline
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040560
Ingredient-typeXanthines
Suppliers and Packaging for NDA: 040560
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 040560 ANDA Mylan Pharamceuticals Inc. 0378-0486 N 0378-0486-01
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 040560 ANDA Mylan Pharamceuticals Inc. 0378-0487 N 0378-0487-01

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Apr 21, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Apr 21, 2006TE:ABRLD:No

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