FDA.reportPublic FDA data

Application 017531

Type
NDA
Sponsor
KING PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
006TIGANTRIMETHOBENZAMIDE HYDROCHLORIDECAPSULE;ORAL300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61570-079TIGANtrimethobenzamide hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
61570-079TIGANtrimethobenzamide hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
61570-079TIGANtrimethobenzamide hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
70518-1225TIGANtrimethobenzamide hydrochlorideREMEDYREPACK INC.NDACurrent
70518-1225TIGANtrimethobenzamide hydrochlorideREMEDYREPACK INC.NDACurrent
70518-1225TIGANtrimethobenzamide hydrochlorideREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47565SUPPL2017-03-14
47564SUPPL2017-03-14
13833SUPPL2008-12-10
33293SUPPL2008-12-08
11015SUPPL2008-03-27
13832SUPPL2008-03-26
20076SUPPL2007-07-06
11014SUPPL2002-04-30
619SUPPL2002-04-30