FDA.reportPublic FDA data

Application 077273

Type
ANDA
Sponsor
ECR PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TUSSICAPSCHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREXCAPSULE, EXTENDED RELEASE;ORALEQ 8MG MALEATE;EQ 10MG BITARTRATENoYes
002TUSSICAPSCHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREXCAPSULE, EXTENDED RELEASE;ORALEQ 4MG MALEATE;EQ 5MG BITARTRATENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0108TussiCapshydrocodone polistirex and chlorpheniramine polistirexVALEANT PHARMACEUTICALS NORTH AMERICA LLCANDACurrent
0187-0108TussiCapshydrocodone polistirex and chlorpheniramine polistirexBausch Health US LLCANDACurrent
0187-0108TussiCapshydrocodone polistirex and chlorpheniramine polistirexBausch Health Americas Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39522ORIG2007-10-04
31215ORIG2007-09-26