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Daiichi Sankyo
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Generated: February 24, 2018

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 five 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 085186
Applicant:Nostrum Labs Inc
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 085186
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 N 0121-4794-15
ELIXOPHYLLIN theophylline SOLUTION, ELIXIR;ORAL 085186 ANDA Atlantic Biologicals Corps 17856-0644 N 17856-0644-2

Profile 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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