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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090355

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NDA 090355 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 090355

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

Pharmacology for NDA: 090355

Ingredient-typeXanthines

Suppliers and Packaging for NDA: 090355

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 090355 ANDA Glenmark Pharmaceuticals Inc., USA 68462-356 68462-356-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-356-01)
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 090355 ANDA Glenmark Pharmaceuticals Inc., USA 68462-356 68462-356-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-356-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Jul 13, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Jul 13, 2010TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

US Army
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