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Deloitte
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Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040560

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NDA 040560 describes THEOPHYLLINE, which is a drug marketed by Alpharma Us Pharms, Pliva, Pharm Assoc, Taro, Alembic Pharms Ltd, Scherer Rp, Hospira, Inwood Labs, Teva Pharms, Roxane, Able, Wockhardt, Chartwell Rx, Cent Pharms, Glenmark Generics, Silarx, Mylan Ireland Ltd, Sandoz, Kv Pharm, Precision Dose, Halsey, Rhodes Pharms, Cenci, Tris Pharma Inc, 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. Thirty suppliers are listed for this compound. Additional details are available on the theophylline profile page.

Summary for 040560

Tradename:
1
Applicant:
1
Ingredient:
1
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 0378-0486-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0486-01)
THEOPHYLLINE
theophylline
TABLET, EXTENDED RELEASE;ORAL 040560 ANDA Mylan Pharamceuticals Inc. 0378-0487 0378-0487-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0487-01)

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
Julphar
Harvard Business School
Express Scripts
Novartis
US Army
US Department of Justice
Deloitte
Merck

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