FDA.reportPublic FDA data

Application 091490

Type
ANDA
Sponsor
RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
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#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42858-001Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-001Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-001Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-001Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-001Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-001Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-002Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-002Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-002Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-002Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-002Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-002Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-003Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-003Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-003Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-003Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-003Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-003Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-004Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-004Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-004Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-004Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-004Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-004Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-005Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-005Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-005Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-005Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-005Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
42858-005Oxycodone HydrochlorideOxycodone HydrochlorideRhodes Pharmaceuticals L.P.ANDACurrent
63629-8526Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-8526Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
68071-2899Oxycodone HydrochlorideOxycodone HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
71335-1413Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1413Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1414Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1414Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1414Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1421Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1421Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1421Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1422Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1422Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1422Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-9606Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76157ORIG 2023-11-03
43252ORIG2012-10-09