FDA.reportPublic FDA data

Application 091422

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

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 BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44556ORIG2015-07-02
9338SUPPL2014-05-29
9337ORIG2013-02-26