FDA.reportPublic FDA data

Application 040400

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-0125HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLCANDACurrent
0406-0125HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLCANDACurrent
0406-0125HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLCANDACurrent
0406-0125HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLCANDACurrent
42549-514HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSTAT Rx USA LLCANDACurrent
45865-411HYDROCODONE BIT/APAPHYDROCODONE BITARTRATE AND ACETAMINOPHENMedsource PharmaceuticalsANDACurrent
60429-592HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical SupplyANDACurrent
60429-592HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply, Inc.ANDACurrent
60429-592HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply, Inc.ANDACurrent
60429-592HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical SupplyANDACurrent
60429-592HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply, Inc.ANDACurrent
60429-592HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply IncANDACurrent
60429-592HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply IncANDACurrent
60429-592HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENGolden State Medical Supply IncANDACurrent
67296-1542HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENRedPharm Drug, Inc.ANDACurrent
67296-1542HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENRedPharm Drug, Inc.ANDACurrent
67296-1542HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENRedPharm Drug, Inc.ANDACurrent
70518-2923HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENREMEDYREPACK INC.ANDACurrent
70518-2923HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENREMEDYREPACK INC.ANDACurrent
72189-399NorcoHydrocodone/APAPDirect_RxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76174ORIG 2023-11-03
7648ORIG2000-07-26