FDA.reportPublic FDA data

Application 203601

Type
ANDA
Sponsor
AVANTHI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDETABLET;ORAL10MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10702-070Oxymorphone HydrochlorideOxymorphone HydrochlorideKVK-Tech, Inc.ANDACurrent
10702-070Oxymorphone HydrochlorideOxymorphone HydrochlorideKVK-Tech, Inc.ANDACurrent
10702-070Oxymorphone HydrochlorideOxymorphone HydrochlorideKVK-Tech, Inc.ANDACurrent
10702-070Oxymorphone HydrochlorideOxymorphone HydrochlorideKVK-Tech, Inc.ANDACurrent
10702-071Oxymorphone HydrochlorideOxymorphone HydrochlorideKVK-Tech, Inc.ANDACurrent
10702-071Oxymorphone HydrochlorideOxymorphone HydrochlorideKVK-Tech, Inc.ANDACurrent
10702-071Oxymorphone HydrochlorideOxymorphone HydrochlorideKVK-Tech, Inc.ANDACurrent
10702-071Oxymorphone HydrochlorideOxymorphone HydrochlorideKVK-Tech, Inc.ANDACurrent
35356-967Oxymorphone HydrochlorideOxymorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-967Oxymorphone HydrochlorideOxymorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-967Oxymorphone HydrochlorideOxymorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-968Oxymorphone HydrochlorideOxymorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-968Oxymorphone HydrochlorideOxymorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-968Oxymorphone HydrochlorideOxymorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76336ORIG 2023-11-03