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Generated: August 19, 2018

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, Lannett Co Inc, 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 nineteen 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-three suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 090355
Tradename:THEOPHYLLINE
Applicant:Glenmark Generics
Ingredient:theophylline
Patents:0
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 N 68462-356-01
THEOPHYLLINE theophylline TABLET, EXTENDED RELEASE;ORAL 090355 ANDA Glenmark Pharmaceuticals Inc., USA 68462-356 N 68462-356-05

Profile for product number 001

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

Profile for product number 002

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

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