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Generated: September 24, 2018

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Details for New Drug Application (NDA): 087449

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NDA 087449 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 087449
Tradename:THEOPHYLLINE
Applicant:Roxane
Ingredient:theophylline
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength80MG/15ML
Approval Date:Sep 15, 1983TE:RLD:No

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