FDA.reportPublic FDA data

Application 210432

Type
ANDA
Sponsor
RISING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREGABALINPREGABALINCAPSULE;ORAL25MGNoNo
002PREGABALINPREGABALINCAPSULE;ORAL50MGNoNo
003PREGABALINPREGABALINCAPSULE;ORAL75MGNoNo
004PREGABALINPREGABALINCAPSULE;ORAL100MGNoNo
005PREGABALINPREGABALINCAPSULE;ORAL150MGNoNo
006PREGABALINPREGABALINCAPSULE;ORAL200MGNoNo
007PREGABALINPREGABALINCAPSULE;ORAL225MGNoNo
008PREGABALINPREGABALINCAPSULE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6991PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-6991PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-6992PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-6992PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-7000PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-7000PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-7001PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-7001PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-7002PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-7002PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-7003PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-7003PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-7004PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-7004PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-7005PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
0904-7005PREGABALINPREGABALINMajor PharmaceuticalsANDACurrent
55154-8097PREGABALINPREGABALINCardinal HealthANDACurrent
55154-8097PREGABALINPREGABALINCardinal Health 107, LLCANDACurrent
55154-8098PREGABALINPREGABALINCardinal HealthANDACurrent
55154-8098PREGABALINPREGABALINCardinal Health 107, LLCANDACurrent
55700-773PREGABALINPREGABALINQuality Care Products, LLCANDACurrent
55700-773PREGABALINPREGABALINQuality Care Products, LLCANDACurrent
55700-774PREGABALINPREGABALINQuality Care Products, LLCANDACurrent
55700-774PREGABALINPREGABALINQuality Care Products, LLCANDACurrent
55700-775PREGABALINPREGABALINQuality Care Products, LLCANDACurrent
55700-775PREGABALINPREGABALINQuality Care Products, LLCANDACurrent
55700-776PREGABALINPREGABALINQuality Care Products, LLCANDACurrent
55700-795PREGABALINPREGABALINQuality Care Products, LLCANDACurrent
55700-795PREGABALINPREGABALINQuality Care Products, LLCANDACurrent
60687-473PregabalinPregabalinAmerican Health PackagingANDACurrent
60687-473PregabalinPregabalinAmerican Health PackagingANDACurrent
60687-473PregabalinPregabalinAmerican Health PackagingANDACurrent
60687-484PregabalinPregabalinAmerican Health PackagingANDACurrent
60687-484PregabalinPregabalinAmerican Health PackagingANDACurrent
60687-484PregabalinPregabalinAmerican Health PackagingANDACurrent
60687-495PregabalinPregabalinAmerican Health PackagingANDACurrent
60687-495PregabalinPregabalinAmerican Health PackagingANDACurrent
60687-495PregabalinPregabalinAmerican Health PackagingANDACurrent
60687-506PregabalinPregabalinAmerican Health PackagingANDACurrent
60687-506PregabalinPregabalinAmerican Health PackagingANDACurrent
60687-506PregabalinPregabalinAmerican Health PackagingANDACurrent
60687-517PregabalinPregabalinAmerican Health PackagingANDACurrent
60687-517PregabalinPregabalinAmerican Health PackagingANDACurrent
60687-517PregabalinPregabalinAmerican Health PackagingANDACurrent
64980-410PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-410PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-410PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-411PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-411PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-411PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-412PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-412PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-412PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-413PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-413PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-413PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-414PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-414PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-414PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-415PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-415PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-415PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-416PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-416PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-416PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-417PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-417PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
64980-417PREGABALINPREGABALINRising Pharmaceuticals, Inc.ANDACurrent
70518-2290PREGABALINPREGABALINREMEDYREPACK INC.ANDACurrent
70518-2290PREGABALINPREGABALINREMEDYREPACK INC.ANDACurrent
70518-2290PREGABALINPREGABALINREMEDYREPACK INC.ANDACurrent
70518-2689PREGABALINPREGABALINREMEDYREPACK INC.ANDACurrent
70518-2689PREGABALINPREGABALINREMEDYREPACK INC.ANDACurrent
70518-2689PREGABALINPREGABALINREMEDYREPACK INC.ANDACurrent
70518-2892PREGABALINPREGABALINREMEDYREPACK INC.ANDACurrent
70518-2892PREGABALINPREGABALINREMEDYREPACK INC.ANDACurrent
71205-298PREGABALINPREGABALINProficient Rx LPANDACurrent
71205-298PREGABALINPREGABALINProficient Rx LPANDACurrent
71205-338PREGABALINPREGABALINProficient Rx LPANDACurrent
71335-1300PREGABALINPREGABALINBryant Ranch PrepackANDACurrent