FDA.reportPublic FDA data

Application 078163

Type
ANDA
Sponsor
ORCHID HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDETABLET;ORALEQ 250MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-501terbinafine hydrochlorideterbinafine hydrochlorideNorthstar Rx LLCANDACurrent
16714-501terbinafine hydrochlorideterbinafine hydrochlorideNorthstar Rx LLCANDACurrent
16714-501terbinafine hydrochlorideterbinafine hydrochlorideNorthstar Rx LLCANDACurrent
42043-410terbinafine hydrochlorideterbinafine hydrochlorideOrchidPharma IncANDACurrent
42043-410terbinafine hydrochlorideterbinafine hydrochlorideOrchidPharma IncANDACurrent
42043-410terbinafine hydrochlorideterbinafine hydrochlorideOrchidPharma IncANDACurrent
68071-2426terbinafine hydrochlorideterbinafine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
69452-351terbinafine hydrochlorideterbinafine hydrochlorideBionpharma Inc.ANDACurrent
71335-1836terbinafine hydrochlorideterbinafine hydrochlorideBryant Ranch PrepackANDACurrent
71335-1836terbinafine hydrochlorideterbinafine hydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9126ORIG2007-07-05