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Last Updated: October 20, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206344


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NDA 206344 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, Glenmark Pharms Ltd, Heritage Pharma, Nostrum Labs Inc, Rhodes Pharms, B Braun, Baxter Hlthcare, and Hospira Inc, and is included in forty-four NDAs. It is available from twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 206344
Tradename:THEOPHYLLINE
Applicant:Pharm Assoc
Ingredient:theophylline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206344
Suppliers and Packaging for NDA: 206344
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE theophylline SOLUTION, ELIXIR;ORAL 206344 ANDA Pharmaceutical Associates, Inc. 0121-0820 0121-0820-04 118 mL in 1 BOTTLE (0121-0820-04)
THEOPHYLLINE theophylline SOLUTION, ELIXIR;ORAL 206344 ANDA Pharmaceutical Associates, Inc. 0121-0820 0121-0820-16 473 mL in 1 BOTTLE (0121-0820-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION, ELIXIR;ORALStrength80MG/15ML
Approval Date:Dec 16, 2016TE:AARLD:No

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