FDA.reportPublic FDA data

Application 090118

Type
ANDA
Sponsor
SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;5MGNoNo
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;7.5MGNoNo
003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-260HYDROCODONE BITARTRATE AND ACETAMINOPHENhydrocodone bitartrate and acetaminophenApotheca Inc.ANDACurrent
21695-386HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENRebel Distributors CorpANDACurrent
42254-214HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENRebel Distributors CorpANDACurrent
42254-340HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENRebel Distributors CorpANDACurrent
50090-1519HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENA-S Medication SolutionsANDACurrent
50090-2772Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-2861Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-4067Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-4067Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-4072Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50436-3918HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENUnit Dose ServicesANDACurrent
50436-3918HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENUnit Dose ServicesANDACurrent
51655-900HYDROCODONE BITARTATE AND ACETAMINOPHENHYDROCODONE BITARTATE AND ACETAMINOPHENNorthwind PharmaceuticalsANDACurrent
51862-227Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMayne Pharma Inc.ANDACurrent
51862-228Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMayne Pharma Inc.ANDACurrent
51862-229Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMayne Pharma Inc.ANDACurrent
51862-585LORCETHydrocodone Bitartrate and AcetaminophenMayne Pharma Inc.ANDACurrent
51862-586LORCET PLUSHydrocodone Bitartrate and AcetaminophenMayne Pharma Inc.ANDACurrent
51862-587LORCET HDHydrocodone Bitartrate and AcetaminophenMayne Pharma Inc.ANDACurrent
57664-126HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.ANDACurrent
57664-126HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.ANDACurrent
57664-170HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.ANDACurrent
57664-170HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.ANDACurrent
57664-176HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.ANDACurrent
57664-176HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.ANDACurrent
61919-452HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect RxANDACurrent
61919-452HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect_RxANDACurrent
61919-452HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect_RxANDACurrent
64725-0026HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENTYA PharmaceuticalsANDACurrent
67296-1238HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENRedPharm Drug, Inc.ANDACurrent
67296-1238HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENRedPharm Drug, Inc.ANDACurrent
71335-0063HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch PrepackANDACurrent
71335-0063HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch PrepackANDACurrent
71335-0063HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch PrepackANDACurrent
71335-0385HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch PrepackANDACurrent
71335-0385HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch PrepackANDACurrent
71335-0385HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch PrepackANDACurrent
71335-0385HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76086ORIG 2023-11-02