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Details for New Drug Application (NDA): 090355

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NDA 090355 describes THEOPHYLLINE, which is a drug marketed by Alpharma Us Pharms, Pliva, Pharm Assoc, Taro, Alembic Ltd, Scherer Rp, Hospira, Inwood Labs, Teva Pharms, Roxane, Able, Wockhardt, Perrigo, 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-three NDAs. It is available from twenty-five 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-two suppliers are listed for this compound. Additional details are available on the theophylline profile page.

Summary for NDA: 090355

Tradename:
THEOPHYLLINE
Applicant:
Glenmark Generics
Ingredient:
theophylline
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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