FDA.reportPublic FDA data

Application 091393

Type
ANDA
Sponsor
AVANTHI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL10MGNoYes
003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL15MGNoNo
004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL20MGNoNo
005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10702-008OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCANDACurrent
10702-009OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCANDACurrent
10702-018OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCANDACurrent
10702-056OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCANDACurrent
10702-057OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCANDACurrent
35356-839Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-839Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-839Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-839Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-839Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA QuaANDACurrent
49999-899Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-899Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-899Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-174OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-174OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-174OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-175OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-509OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-509OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEQuality Care Products, LLCANDACurrent
55700-509OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-509OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEQuality Care Products, LLCANDACurrent
67296-0832OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
67296-0832OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
67296-0832OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
68084-354OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-354OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-354OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-968OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-968OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-968OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-975OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-975OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-975OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-983OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-983OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-983OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
71335-1245OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
72189-094OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXANDACurrent
72189-094OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXANDACurrent
72189-094OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76319ORIG 2023-11-03