FDA.reportPublic FDA data

Application 020989

Type
NDA
Sponsor
DAIICHI SANKYO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002EVOXACCEVIMELINE HYDROCHLORIDECAPSULE;ORAL30MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0883Evoxaccevimeline hydrochlorideCosette Pharmaceuticals, Inc.NDACurrent
0713-0883Evoxaccevimeline hydrochlorideCosette Pharmaceuticals, Inc.NDACurrent
0713-0937cevimeline hydrochloridecevimeline hydrochlorideCosette Pharmaceuticals, Inc.NDACurrent
63304-479CevimelineCevimelineSun Pharmaceutical Industries, Inc.NDACurrent
63304-479CevimelineCevimelineSun Pharmaceutical Industries, Inc.NDACurrent
63304-479CevimelineCevimelineSun Pharmaceutical Industries, Inc.NDACurrent
63304-479CevimelineCevimelineSun Pharmaceutical Industries, Inc.NDACurrent
63304-479CevimelineCevimelineSun Pharmaceutical Industries, Inc.NDACurrent
63395-201Evoxaccevimeline hydrochlorideDaiichi Sankyo, Inc.NDACurrent
63395-201Evoxaccevimeline hydrochlorideDaiichi Sankyo, Inc.NDACurrent
63395-201Evoxaccevimeline hydrochlorideDaiichi Sankyo, Inc.NDACurrent
63395-201Evoxaccevimeline hydrochlorideDaiichi Sankyo, Inc.NDACurrent
63395-201Evoxaccevimeline hydrochlorideDaiichi Sankyo, Inc.NDACurrent
63395-201Evoxaccevimeline hydrochlorideDaiichi Sankyo, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
26411SUPPL2006-12-28
35827SUPPL2006-12-14
3982SUPPL2005-12-16
14110SUPPL2005-12-15
41864ORIG2000-01-11
35826ORIG2000-01-11
3981ORIG2000-01-11