FDA.report

Application 204021

Type
ANDA
Sponsor
NOVEL LABS INC

Related Records

Application Products

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

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-430Oxycodone HydrochlorideOxycodone HydrochlorideNovel Laboratories, Inc.ANDACurrent
40032-431Oxycodone HydrochlorideOxycodone HydrochlorideNovel Laboratories, Inc.ANDACurrent
40032-432Oxycodone HydrochlorideOxycodone HydrochlorideNovel Laboratories, Inc.ANDACurrent
40032-433Oxycodone HydrochlorideOxycodone HydrochlorideNovel Laboratories, Inc.ANDACurrent
40032-434Oxycodone HydrochlorideOxycodone HydrochlorideNovel Laboratories, Inc.ANDACurrent
43386-430Oxycodone HydrochlorideOxycodone HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-430Oxycodone HydrochlorideOxycodone HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-431Oxycodone HydrochlorideOxycodone HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-431Oxycodone HydrochlorideOxycodone HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-432Oxycodone HydrochlorideOxycodone HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-432Oxycodone HydrochlorideOxycodone HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-433Oxycodone HydrochlorideOxycodone HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-433Oxycodone HydrochlorideOxycodone HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-434Oxycodone HydrochlorideOxycodone HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-434Oxycodone HydrochlorideOxycodone HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
51407-529Oxycodone HydrochlorideOxycodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-529Oxycodone HydrochlorideOxycodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-530Oxycodone HydrochlorideOxycodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-531Oxycodone HydrochlorideOxycodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-532Oxycodone HydrochlorideOxycodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-533Oxycodone HydrochlorideOxycodone HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
72189-095OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXANDACurrent
72189-095OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXANDACurrent
72189-095OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXANDACurrent

Documents

DocumentSubmission typeDate
76128ORIG 2023-11-03
48752ORIG2017-06-16