FDA.reportPublic FDA data

Application 090819

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

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
0228-3153BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3153BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3153BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3153BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3153BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3153BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3153BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3153BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3153BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3153BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3156BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3156BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3156BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3156BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3156BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3156BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3156BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3156BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3156BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
0228-3156BuprenorphineBuprenorphineActavis Pharma, Inc.ANDACurrent
50090-2924BuprenorphineBuprenorphine HydrochlorideA-S Medication SolutionsANDACurrent
58118-3156BuprenorphineBuprenorphineClinical Solutions Wholesale, LLCANDACurrent
58118-3156BuprenorphineBuprenorphineClinical Solutions Wholesale, LLCANDACurrent
70518-1557BuprenorphineBuprenorphineREMEDYREPACK INC.ANDACurrent
70518-1557BuprenorphineBuprenorphineREMEDYREPACK INC.ANDACurrent
70518-1625BuprenorphineBuprenorphineREMEDYREPACK INC.ANDACurrent
70518-1625BuprenorphineBuprenorphineREMEDYREPACK INC.ANDACurrent
70518-1625BuprenorphineBuprenorphineREMEDYREPACK INC.ANDACurrent
71335-0353BuprenorphineBuprenorphineBryant Ranch PrepackANDACurrent
71335-0353BuprenorphineBuprenorphineBryant Ranch PrepackANDACurrent
71335-0353BuprenorphineBuprenorphineBryant Ranch PrepackANDACurrent
71335-0353BuprenorphineBuprenorphineBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44554ORIG2015-07-02
31499ORIG2015-02-24