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Generated: July 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090430

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NDA 090430 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: 090430

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

Pharmacology for NDA: 090430

Ingredient-typeXanthines

Suppliers and Packaging for NDA: 090430

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE
theophylline
TABLET, EXTENDED RELEASE;ORAL 090430 ANDA Heritage Pharmaceuticals Inc. 23155-062 23155-062-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-062-01)
THEOPHYLLINE
theophylline
TABLET, EXTENDED RELEASE;ORAL 090430 ANDA Heritage Pharmaceuticals Inc. 23155-062 23155-062-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-062-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Oct 27, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength450MG
Approval Date:Oct 27, 2010TE:RLD:No


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Covington
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