FDA.reportPublic FDA data

Application 040409

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANEXSIA 5/325ACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-0123HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLCANDACurrent
0406-0123HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLCANDACurrent
0406-0123HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLCANDACurrent
0406-0123HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLCANDACurrent
42549-556HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSTAT Rx USA LLCANDACurrent
60429-590HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply IncANDACurrent
60429-590HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply IncANDACurrent
60429-590HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply IncANDACurrent
60429-590HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply, Inc.ANDACurrent
60429-590HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical SupplyANDACurrent
60429-590HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical SupplyANDACurrent
60429-590HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply, Inc.ANDACurrent
60429-590HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply, Inc.ANDACurrent
63629-5436HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch PrepackANDACurrent
67296-0362HYDROCODONE BITARTRATE AND ACETAMINOPHENhydrocodone bitartrate and acetaminophenRedPharm Drug Inc.ANDACurrent
72189-407NorcoHydrocodone/APAPDirect_RxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76180ORIG 2023-11-03
7652ORIG2000-10-20