FDA.reportPublic FDA data

Application 211360

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDENAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL220MG;120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58602-816Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and ColdNaproxen Sodium and Pseudoephedrine HydrochlorideAurohealth LLCANDACurrent
58602-832Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and HeadacheNaproxen Sodium and Pseudoephedrine HydrochlorideAurohealth LLCANDACurrent