FDA.reportPublic FDA data

Application 089808

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THEOPHYLLINETHEOPHYLLINETABLET, EXTENDED RELEASE;ORAL200MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-2503Theophylline Extended ReleaseTheophylline, anhydrousNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
50111-482TheophyllineTheophyllineTeva Pharmaceuticals USA, Inc.ANDACurrent
53808-0315TheophyllineTheophyllineState of Florida DOH Central PharmacyANDACurrent
63629-2792TheophyllineTheophyllineBryant Ranch PrepackANDACurrent
68788-0453TheophyllineTheophyllinePreferred PharmaceuticalsANDACurrent