Application 021256

Type
NDA
Sponsor
CHIRHOCLIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHIRHOSTIMSECRETIN SYNTHETIC HUMANFOR SOLUTION;INTRAVENOUS16MCG/VIALYesYes
002CHIRHOSTIMSECRETIN SYNTHETIC HUMANFOR SOLUTION;INTRAVENOUS40MCG/VIALYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67066-005ChiRhoStimHuman SecretinChiRhoClin, Inc.NDACurrent
67066-005ChiRhoStimHuman SecretinChiRhoClin, Inc.NDACurrent
67066-005ChiRhoStimHuman SecretinChiRhoClin, Inc.NDACurrent
67066-007ChiRhoStim 40Human SecretinChiRhoClin, Inc.NDACurrent
67066-007ChiRhoStim 40Human SecretinChiRhoClin, Inc.NDACurrent
67066-007ChiRhoStim 40Human SecretinChiRhoClin, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49032SUPPL2017-07-21
49017SUPPL2017-07-19
4801SUPPL2007-07-05
4800SUPPL2007-07-05
36481SUPPL2007-06-27
27232SUPPL2004-09-10
21552ORIG2004-08-09
14763ORIG2004-05-03
4799ORIG2004-04-20