FDA.reportPublic FDA data

Application 211111

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOCINONIDEFLUOCINONIDECREAM;TOPICAL0.1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68788-7541FluocinonideFluocinonidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7541FluocinonideFluocinonidePreferred Pharmaceuticals Inc.ANDACurrent
69238-1271FluocinonideFluocinonideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1271FluocinonideFluocinonideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1271FluocinonideFluocinonideAmneal Pharmaceuticals LLCANDACurrent
69238-1271FluocinonideFluocinonideAmneal Pharmaceuticals NY LLCANDACurrent
76420-530FluocinonideFluocinonideAsclemed USA, Inc.ANDACurrent