FDA.reportPublic FDA data

Application 072267

Type
ANDA
Sponsor
XSPIRE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOPROFEN CALCIUMFENOPROFEN CALCIUMTABLET;ORALEQ 600MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0471Fenoprofen CalciumFenoprofen CalciumMylan Pharmaceuticals Inc.ANDACurrent
42195-471Fenoprofen CalciumFenoprofen CalciumXspire Pharma, LlcANDACurrent
42195-471Fenoprofen CalciumFenoprofen CalciumXspire Pharma, LlcANDACurrent
42195-471Fenoprofen CalciumFenoprofen CalciumXspire Pharma, LlcANDACurrent
42195-471Fenoprofen CalciumFenoprofen CalciumXspire Pharma, LlcANDACurrent
42195-471Fenoprofen CalciumFenoprofen CalciumXspire Pharma, LlcANDACurrent
42195-688NALFONFenoprofen CalciumXspire Pharma, LLCANDACurrent
42195-688NALFONFenoprofen CalciumXspire Pharma, LLCANDACurrent
42195-688NALFONFenoprofen CalciumXspire Pharma, LLCANDACurrent
42195-688NALFONFenoprofen CalciumXspire Pharma, LLCANDACurrent
55289-334Fenoprofen CalciumFenoprofen CalciumPD-Rx Pharmaceuticals, Inc.ANDACurrent
66992-471ProFenofenoprofen calciumWraser LLCANDACurrent