FDA.reportPublic FDA data

Application 040654

Type
ANDA
Sponsor
VINTAGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDESYRUP;ORAL5MG/5ML;6.25MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0926Promethazine VCPromethazine Hydrochloride and Phenylephrine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0603-1587Promethazine VCPromethazine hydrochloride and phenylephrine hydrochloridePar PharmaceuticalANDACurrent
0603-1587Promethazine VCPromethazine hydrochloride and phenylephrine hydrochloridePar PharmaceuticalANDACurrent
68788-6763Promethazine VCPromethazinehydrochloride and phenylephrine hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9100Promethazine VCPromethazinehydrochloride and phenylephrine hydrochloridePreferred Pharmaceuticals, IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23716ORIG2006-12-18