FDA.reportPublic FDA data

Application 209037

Type
ANDA
Sponsor
ABHAI LLC

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
10702-189Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-189Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-189Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-189Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-190Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-190Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-190Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-190Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-191Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-191Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-191Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-191Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
55700-598Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-598Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-598Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-598Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-598Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-598Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-603Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-603Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-652Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-652Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-652Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-652Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-652Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-652Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-652Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-652Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-652Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-652Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-652Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
67296-1618Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1618Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1618Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1618Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1623Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1623Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1623Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1631Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1631Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
72189-191HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirectRxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76296ORIG 2023-11-03