FDA.reportPublic FDA data

Application 207333

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1669Oxycodone and AcetaminophenOxycodone and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1669Oxycodone and AcetaminophenOxycodone and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1669Oxycodone and AcetaminophenOxycodone and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1669Oxycodone and AcetaminophenOxycodone and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1669Oxycodone and AcetaminophenOxycodone and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1671Oxycodone and AcetaminophenOxycodone and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1671Oxycodone and AcetaminophenOxycodone and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1671Oxycodone and AcetaminophenOxycodone and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1671Oxycodone and AcetaminophenOxycodone and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1671Oxycodone and AcetaminophenOxycodone and AcetaminophenLannett Company, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76102ORIG 2023-11-02
49878ORIG2017-09-28