FDA.reportPublic FDA data

Application 205601

Type
ANDA
Sponsor
RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 2MG BASE;EQ 0.5MG BASENoNo
002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 8MG BASE;EQ 2MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42858-601Buprenorphine and NaloxoneBuprenorphine and NaloxoneRhodes Pharmaceuticals L.P.ANDACurrent
42858-601Buprenorphine and NaloxoneBuprenorphine and NaloxoneRhodes Parmaceuticals L.P.ANDACurrent
42858-601Buprenorphine and NaloxoneBuprenorphine and NaloxoneRhodes Pharmaceuticals L.P.ANDACurrent
42858-601Buprenorphine and NaloxoneBuprenorphine and NaloxoneRhodes Pharmaceuticals L.P.ANDACurrent
42858-602Buprenorphine and NaloxoneBuprenorphine and NaloxoneRhodes Pharmaceuticals L.P.ANDACurrent
42858-602Buprenorphine and NaloxoneBuprenorphine and NaloxoneRhodes Pharmaceuticals L.P.ANDACurrent
42858-602Buprenorphine and NaloxoneBuprenorphine and NaloxoneRhodes Parmaceuticals L.P.ANDACurrent
42858-602Buprenorphine and NaloxoneBuprenorphine and NaloxoneRhodes Pharmaceuticals L.P.ANDACurrent
60687-626Buprenorphine and NaloxoneBuprenorphine and NaloxoneAmerican Health PackagingANDACurrent
60687-637Buprenorphine and NaloxoneBuprenorphine and NaloxoneAmerican Health PackagingANDACurrent
63629-9482Buprenorphine and NaloxoneBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
63629-9482Buprenorphine and NaloxoneBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
63629-9483Buprenorphine and NaloxoneBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
70518-3389Buprenorphine and NaloxoneBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-3389Buprenorphine and NaloxoneBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-3487Buprenorphine and NaloxoneBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-3487Buprenorphine and NaloxoneBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76393ORIG 2023-11-06