FDA.reportPublic FDA data

Application 204407

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;2.5MGNoNo
002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;5MGNoNo
003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;7.5MGNoNo
004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43386-490Oxycodone and AcetaminophenOxycodone and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-490Oxycodone and AcetaminophenOxycodone and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-490Oxycodone and AcetaminophenOxycodone and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-491Oxycodone and AcetaminophenOxycodone and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-491Oxycodone and AcetaminophenOxycodone and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-491Oxycodone and AcetaminophenOxycodone and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-492Oxycodone and AcetaminophenOxycodone and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-492Oxycodone and AcetaminophenOxycodone and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-492Oxycodone and AcetaminophenOxycodone and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-493Oxycodone and AcetaminophenOxycodone and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-493Oxycodone and AcetaminophenOxycodone and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-493Oxycodone and AcetaminophenOxycodone and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76129ORIG 2023-11-03