Application 077712

Type
ANDA
Sponsor
VINTAGE PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL15MGNoNo
002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL30MGNoNo
003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL5MGNoNo
004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL10MGNoNo
005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL20MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-4990Oxycodone HydrochlorideOxycodone HydrochloridePar PharmaceuticalANDACurrent
0603-4990Oxycodone HydrochlorideOxycodone HydrochloridePar PharmaceuticalANDACurrent
0603-4991Oxycodone HydrochlorideOxycodone HydrochloridePar PharmaceuticalANDACurrent
0603-4991Oxycodone HydrochlorideOxycodone HydrochloridePar PharmaceuticalANDACurrent
0603-4992Oxycodone HydrochlorideOxycodone HydrochloridePar PharmaceuticalANDACurrent
0603-4992Oxycodone HydrochlorideOxycodone HydrochloridePar PharmaceuticalANDACurrent
0603-4993Oxycodone HydrochlorideOxycodone HydrochloridePar PharmaceuticalANDACurrent
0603-4993Oxycodone HydrochlorideOxycodone HydrochloridePar PharmaceuticalANDACurrent
0603-4994Oxycodone HydrochlorideOxycodone HydrochloridePar PharmaceuticalANDACurrent
0603-4994Oxycodone HydrochlorideOxycodone HydrochloridePar PharmaceuticalANDACurrent
0904-6590Oxycodone HydrochlorideOxycodone HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6590Oxycodone HydrochlorideOxycodone HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6591Oxycodone HydrochlorideOxycodone HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6591Oxycodone HydrochlorideOxycodone HydrochlorideMajor PharmaceuticalsANDACurrent
21695-254Oxycodone HydrochlorideOxycodone HydrochlorideRebel Distributors CorpANDACurrent
52959-129Oxycodone HydrochlorideOxycodone HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
52959-131Oxycodone HydrochlorideOxycodone HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
63629-4155oxycodone hydrochlorideoxycodone hydrochloridebryant ranch prepackANDACurrent
63629-4184Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent

Documents

DocumentSubmission typeDate
76152ORIG 2023-11-03
22609ORIG2012-09-12