FDA.reportPublic FDA data

Application 091601

Type
ANDA
Sponsor
TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDESOLUTION;ORAL5MG/5MLNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDESOLUTION;ORAL10MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27808-058Methylphenidate HydrochlorideMethylphenidate HydrochlorideTris Pharma IncANDACurrent
27808-058Methylphenidate HydrochlorideMethylphenidate HydrochlorideTris Pharma IncANDACurrent
27808-058Methylphenidate HydrochlorideMethylphenidate HydrochlorideTris Pharma IncANDACurrent
27808-058Methylphenidate HydrochlorideMethylphenidate HydrochlorideTris Pharma IncANDACurrent
27808-059Methylphenidate HydrochlorideMethylphenidate HydrochlorideTris Pharma IncANDACurrent
27808-059Methylphenidate HydrochlorideMethylphenidate HydrochlorideTris Pharma IncANDACurrent
27808-059Methylphenidate HydrochlorideMethylphenidate HydrochlorideTris Pharma IncANDACurrent
27808-059Methylphenidate HydrochlorideMethylphenidate HydrochlorideTris Pharma IncANDACurrent
51991-712Methylphenidate HydrochlorideMethylphenidate HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-713Methylphenidate HydrochlorideMethylphenidate HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9345ORIG2010-07-28