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Generated: November 21, 2018

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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. Twenty-three suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 085186
Tradename:ELIXOPHYLLIN
Applicant:Nostrum Labs Inc
Ingredient:theophylline
Patents:0
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)

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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