FDA.reportPublic FDA data

Application 207276

Type
ANDA
Sponsor
RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPRENORPHINE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDETABLET;SUBLINGUALEQ 2MG BASENoNo
002BUPRENORPHINE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDETABLET;SUBLINGUALEQ 8MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42858-501BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals L.P.ANDACurrent
42858-501BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals L.P.ANDACurrent
42858-501BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals L.P.ANDACurrent
42858-501BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals L.P.ANDACurrent
42858-501BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals L.P.ANDACurrent
42858-501BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals L.P.ANDACurrent
42858-501BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals L.P.ANDACurrent
42858-502BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals L.P.ANDACurrent
42858-502BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals L.P.ANDACurrent
42858-502BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals L.P.ANDACurrent
42858-502BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals L.P.ANDACurrent
42858-502BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals L.P.ANDACurrent
42858-502BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals L.P.ANDACurrent
42858-502BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals L.P.ANDACurrent
50090-5805BUPRENORPHINEBUPRENORPHINEA-S Medication SolutionsANDACurrent
58118-0501BUPRENORPHINEBUPRENORPHINEClinical Solutions Wholesale, LLCANDACurrent
58118-0502BUPRENORPHINEBUPRENORPHINEClinical Solutions Wholesale, LLCANDACurrent
60687-481BuprenorphineBuprenorphineAmerican Health PackagingANDACurrent
60687-481BuprenorphineBuprenorphineAmerican Health PackagingANDACurrent
60687-481BuprenorphineBuprenorphineAmerican Health PackagingANDACurrent
60687-492BuprenorphineBuprenorphineAmerican Health PackagingANDACurrent
60687-492BuprenorphineBuprenorphineAmerican Health PackagingANDACurrent
60687-492BuprenorphineBuprenorphineAmerican Health PackagingANDACurrent
63629-9475BUPRENORPHINEBUPRENORPHINEBryant Ranch PrepackANDACurrent
68071-2592BUPRENORPHINEBUPRENORPHINENuCare Pharmaceuticals,Inc.ANDACurrent
70518-2217BUPRENORPHINEBUPRENORPHINEREMEDYREPACK INC.ANDACurrent
70518-2217BUPRENORPHINEBUPRENORPHINEREMEDYREPACK INC.ANDACurrent
70518-2218BUPRENORPHINEBUPRENORPHINEREMEDYREPACK INC.ANDACurrent
70518-2218BUPRENORPHINEBUPRENORPHINEREMEDYREPACK INC.ANDACurrent
71335-0950BUPRENORPHINEBUPRENORPHINEBryant Ranch PrepackANDACurrent
71335-0950BUPRENORPHINEBUPRENORPHINEBryant Ranch PrepackANDACurrent
71335-0950BUPRENORPHINEBUPRENORPHINEBryant Ranch PrepackANDACurrent
71335-0950BUPRENORPHINEBUPRENORPHINEBryant Ranch PrepackANDACurrent
71335-1154BUPRENORPHINEBUPRENORPHINEBryant Ranch PrepackANDACurrent
71335-1154BUPRENORPHINEBUPRENORPHINEBryant Ranch PrepackANDACurrent
71335-1154BUPRENORPHINEBUPRENORPHINEBryant Ranch PrepackANDACurrent
71335-1154BUPRENORPHINEBUPRENORPHINEBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76374ORIG 2023-11-06
50042APPL2017-10-12