FDA.reportPublic FDA data

Application 208516

Type
ANDA
Sponsor
SUNNY PHARMTECH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL75MG;25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13811-719NitrofurantoinNitrofurantoinTrigen Laboratories, LLCANDACurrent
13811-719NitrofurantoinNitrofurantoinTrigen Laboratories, LLCANDACurrent
13811-719NitrofurantoinNitrofurantoinTrigen Laboratories, LLCANDACurrent
63629-2464NitrofurantoinNitrofurantoinBryant Ranch PrepackANDACurrent
63629-2464NitrofurantoinNitrofurantoinBryant Ranch PrepackANDACurrent
63629-2464NitrofurantoinNitrofurantoinBryant Ranch PrepackANDACurrent
63629-2464NitrofurantoinNitrofurantoinBryant Ranch PrepackANDACurrent
63629-2464NitrofurantoinNitrofurantoinBryant Ranch PrepackANDACurrent
63629-9191NitrofurantoinNitrofurantoinBryant Ranch PrepackANDACurrent
63629-9191NitrofurantoinNitrofurantoinBryant Ranch PrepackANDACurrent
68001-423NitrofurantoinNitrofurantoinBluePoint LaboratoriesANDACurrent
68788-8258NitrofurantoinNitrofurantoinPreferred Pharmaceuticals Inc.ANDACurrent
71205-852NitrofurantoinNitrofurantoinProficient Rx LPANDACurrent
72189-395MacrobidNitrofurantoin Mono/MacroDirect_RxANDACurrent