FDA.reportPublic FDA data

Application 201633

Type
ANDA
Sponsor
SUN PHARM

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
62756-969Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-969Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-969Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-969Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-969Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-969Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-969Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-969Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-969Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-969Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-969Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-970Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-970Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-970Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-970Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-970Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-970Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-970Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-970Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-970Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-970Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
62756-970Buprenorphine and NaloxoneBuprenorphine and NaloxoneSun Pharmaceutical Industries, Inc.ANDACurrent
70518-3129Buprenorphine and NaloxoneBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-3603Buprenorphine and NaloxoneBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76368ORIG 2023-11-06
50043APPL2017-10-12