FDA.reportPublic FDA data

Application 208633

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXAPROZINOXAPROZINTABLET;ORAL600MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60760-092OxaprozinOxaprozinSt Mary's Medical Park PharmacyANDACurrent
69238-1120OxaprozinOxaprozinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1120OxaprozinOxaprozinAmneal Pharmaceuticals LLCANDACurrent
69238-1120OxaprozinOxaprozinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1120OxaprozinOxaprozinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1120OxaprozinOxaprozinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1120OxaprozinOxaprozinAmneal Pharmaceuticals NY LLCANDACurrent
70332-311OxaprozinOxaprozinCalifornia Pharmaceutical LLCANDACurrent
71335-0617OxaprozinOxaprozinBryant Ranch PrepackANDACurrent
71335-0617OxaprozinOxaprozinBryant Ranch PrepackANDACurrent
71335-0617OxaprozinOxaprozinBryant Ranch PrepackANDACurrent
72189-077OXAPROZINOXAPROZINDIRECT RXANDACurrent