FDA.reportPublic FDA data

Application 091156

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THEOPHYLLINETHEOPHYLLINESOLUTION;ORAL80MG/15MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-604TheophyllineTheophylline AnhydrousMarlex Pharmaceuticals IncANDACurrent
10135-604TheophyllineTheophylline AnhydrousMarlex Pharmaceuticals IncANDACurrent
54838-556TheophyllineTheophyllineLannett Company, Inc.ANDACurrent
54838-556TheophyllineTheophyllineLannett Company, Inc.ANDACurrent
54838-556TheophyllineTheophyllineLannett Company, Inc.ANDACurrent
54838-556TheophyllineTheophyllineLannett Company, Inc.ANDACurrent
60687-258TheophyllineTheophyllineAmerican Health PackagingANDACurrent
60687-258TheophyllineTheophyllineAmerican Health PackagingANDACurrent
60687-258TheophyllineTheophyllineAmerican Health PackagingANDACurrent
62135-556TheophyllineTheophyllineChartwell RX, LLCANDACurrent