FDA.reportPublic FDA data

Application 040405

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANEXSIA 7.5/325ACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;7.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-0124HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLCANDACurrent
0406-0124HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLCANDACurrent
0406-0124HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLCANDACurrent
0406-0124HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLCANDACurrent
42549-557HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSTAT Rx USA LLCANDACurrent
60429-591HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply IncANDACurrent
60429-591HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply IncANDACurrent
60429-591HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply IncANDACurrent
60429-591HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply, Inc.ANDACurrent
60429-591HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical SupplyANDACurrent
60429-591HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical SupplyANDACurrent
60429-591HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply, Inc.ANDACurrent
60429-591HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply, Inc.ANDACurrent
72189-406NorcoHYDROCODONE/APAPDirect_RxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76171ORIG 2023-11-03
7651ORIG2000-09-08