FDA.reportPublic FDA data

Application 091632

Type
ANDA
Sponsor
TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREXCHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREXSUSPENSION, EXTENDED RELEASE;ORALEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0087Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0087Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0087Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0087Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0087Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0235Hydrocodone Polistirex and Chlorpheniramine PolisitrexHydrocodone Polistirex and Chlorpheniramine PolisitrexAtlantic Biologicals CorpsANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexTris Pharma IncANDACurrent
63629-2303Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexBryant Ranch PrepackANDACurrent
63629-2303Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexBryant Ranch PrepackANDACurrent
63629-2303Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexBryant Ranch PrepackANDACurrent
63629-2304Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexBryant Ranch PrepackANDACurrent
63629-2304Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexBryant Ranch PrepackANDACurrent
63629-2304Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine PolistirexBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43255ORIG2013-02-01