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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085186

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NDA 085186 describes ELIXOPHYLLIN, which is a drug marketed by Forest Labs and Nostrum Labs Inc and is included in four NDAs. It is available from four suppliers. Additional details are available on the ELIXOPHYLLIN profile page.

The generic ingredient in ELIXOPHYLLIN 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: 085186

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

Pharmacology for NDA: 085186

Ingredient-typeXanthines

Suppliers and Packaging for NDA: 085186

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELIXOPHYLLIN
theophylline
SOLUTION, ELIXIR;ORAL 085186 ANDA Pharmaceutical Associates, Inc. 0121-4794 0121-4794-15 4 TRAY in 1 CASE (0121-4794-15) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE
ELIXOPHYLLIN
theophylline
SOLUTION, ELIXIR;ORAL 085186 ANDA Atlantic Biologicals Corps 17856-0644 17856-0644-1 15 mL in 1 CUP (17856-0644-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION, ELIXIR;ORALStrength80MG/15ML
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Federal Trade Commission
Healthtrust
Mallinckrodt
Cipla
Cantor Fitzgerald
Queensland Health
Medtronic
McKesson
AstraZeneca

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