FDA.reportPublic FDA data

Application 076264

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDETABLET;ORAL25MGNoNo
002NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDETABLET;ORAL50MGNoYes
003NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-1170NALTREXONE HYDROCHLORIDEnaltrexone hydrochlorideSpecGx LLCANDACurrent
0406-1170NALTREXONE HYDROCHLORIDEnaltrexone hydrochlorideSpecGx LLCANDACurrent
0406-1170NALTREXONE HYDROCHLORIDEnaltrexone hydrochlorideSpecGx LLCANDACurrent
0406-1170NALTREXONE HYDROCHLORIDEnaltrexone hydrochlorideSpecGx LLCANDACurrent
68084-291NALTREXONE HYDROCHLORIDEnaltrexone hydrochlorideAmerican Health PackagingANDACurrent
68084-291NALTREXONE HYDROCHLORIDEnaltrexone hydrochlorideAmerican Health PackagingANDACurrent
68084-291NALTREXONE HYDROCHLORIDEnaltrexone hydrochlorideAmerican Health PackagingANDACurrent
68084-291NALTREXONE HYDROCHLORIDEnaltrexone hydrochlorideAmerican Health PackagingANDACurrent
70518-1312NALTREXONE HYDROCHLORIDEnaltrexone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1312NALTREXONE HYDROCHLORIDEnaltrexone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1312NALTREXONE HYDROCHLORIDEnaltrexone hydrochlorideREMEDYREPACK INC.ANDACurrent
71335-1480NALTREXONE HYDROCHLORIDEnaltrexone hydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22552ORIG2007-05-09
8882ORIG2003-04-11