FDA.reportPublic FDA data

Application 077533

Type
ANDA
Sponsor
INVAGEN PHARMS

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
21695-630Terbinafine HydrochlorideTerbinafine HydrochlorideRebel Distributors CorpANDACurrent
31722-209Terbinafine HydrochlorideTerbinafineCamber Pharmaceuticals, Inc.ANDACurrent
63187-213Terbinafine HydrochlorideTerbinafineProficient Rx LPANDACurrent
63187-213Terbinafine HydrochlorideTerbinafineProficient Rx LPANDACurrent
63187-213Terbinafine HydrochlorideTerbinafineProficient Rx LPANDACurrent
63629-2807Terbinafine HydrochlorideTerbinafineBryant Ranch PrepackANDACurrent
64679-209Terbinafine HydrochlorideTerbinafine HydrochlorideWockhardt USA, LLCANDACurrent
68151-1327Terbinafine HydrochlorideTerbinafineCarilion Materials ManagementANDACurrent
68788-7722TerbinafineTerbinafinePreferred Pharmaceuticals, Inc.ANDACurrent
69097-859TerbinafineTerbinafineCipla USA Inc.ANDACurrent
69097-859TerbinafineTerbinafineCipla USA Inc.ANDACurrent
69097-859TerbinafineTerbinafineCipla USA Inc.ANDACurrent
70518-1191TerbinafineTerbinafineREMEDYREPACK INC.ANDACurrent
70518-1191TerbinafineTerbinafineREMEDYREPACK INC.ANDACurrent
70518-1191TerbinafineTerbinafineREMEDYREPACK INC.ANDACurrent
70518-1191TerbinafineTerbinafineREMEDYREPACK INC.ANDACurrent
70518-1191TerbinafineTerbinafineREMEDYREPACK INC.ANDACurrent
70518-1191TerbinafineTerbinafineREMEDYREPACK INC.ANDACurrent
70518-1191TerbinafineTerbinafineREMEDYREPACK INC.ANDACurrent
71205-152TerbinafineTerbinafineProficient Rx LPANDACurrent
71205-152TerbinafineTerbinafineProficient Rx LPANDACurrent
71205-152TerbinafineTerbinafineProficient Rx LPANDACurrent
71335-1668TerbinafineTerbinafineBryant Ranch PrepackANDACurrent
71335-1668TerbinafineTerbinafineBryant Ranch PrepackANDACurrent
71335-1668TerbinafineTerbinafineBryant Ranch PrepackANDACurrent
76282-209TerbinafineTerbinafineExelan Pharmaceuticals Inc.ANDACurrent
76282-209TerbinafineTerbinafineExelan Pharmaceuticals Inc.ANDACurrent
76282-209TerbinafineTerbinafineExelan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31260ORIG2007-07-05