FDA.reportPublic FDA data

Application 203166

Type
ANDA
Sponsor
NEXGEN PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NABUMETONENABUMETONETABLET;ORAL500MGNoNo
002NABUMETONENABUMETONETABLET;ORAL750MGNoNo
003NABUMETONENABUMETONETABLET;ORAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0722-7076Nabumetone 500 mgNabumetoneNexgen Pharma, Inc.ANDACurrent
0722-7077Nabumetone 750 mgNabumetoneNexgen Pharma, Inc.ANDACurrent
0722-7078Nabumetone 1000 mgNabumetoneNexgen Pharma, Inc.ANDACurrent
15370-170RELAFEN DSNABUMETONECarwin Pharmaceutical Associates, LLCANDACurrent
15370-170RELAFEN DSNABUMETONECarwin Pharmaceutical Associates, LLCANDACurrent
15370-170RELAFEN DSNABUMETONECarwin Pharmaceutical Associates, LLCANDACurrent
15370-170RELAFEN DSNABUMETONECarwin Pharmaceutical Associates, LLCANDACurrent
73684-100RELAFENNABUMETONEBLUCREST PHARMACEUTICALS LLCANDACurrent
73684-100RELAFENNABUMETONEBLUCREST PHARMACEUTICALS LLCANDACurrent
73684-101RELAFENNABUMETONEBLUCREST PHARMACEUTICALS LLCANDACurrent
73684-101RELAFENNABUMETONEBLUCREST PHARMACEUTICALS LLCANDACurrent
79739-7076Nabumetone 500 mgNabumetoneLGM Pharma Solutions, LLCANDACurrent
79739-7076Nabumetone 500 mgNabumetoneLGM Pharma Solutions, LLCANDACurrent
79739-7077Nabumetone 750 mgNabumetoneLGM Pharma Solutions, LLCANDACurrent
79739-7077Nabumetone 750 mgNabumetoneLGM Pharma Solutions, LLCANDACurrent
79739-7078Nabumetone 1000 mgNabumetoneLGM Pharma Solutions, LLCANDACurrent
79739-7078Nabumetone 1000 mgNabumetoneLGM Pharma Solutions, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60146ORIG2019-09-27