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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
US Army
Harvard Business School

Generated: September 26, 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 NDA: 040560

Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040560


Suppliers and Packaging for NDA: 040560

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
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 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Fish and Richardson
Chinese Patent Office
Daiichi Sankyo
US Department of Justice
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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