FDA.reportPublic FDA data

Application 090622

Type
ANDA
Sponsor
ETHYPHARM

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
35356-556buprenorphine hydrochloridebuprenorphine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1571buprenorphine hydrochloridebuprenorphine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1571buprenorphine hydrochloridebuprenorphine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1571buprenorphine hydrochloridebuprenorphine hydrochlorideA-S Medication SolutionsANDACurrent
50383-924buprenorphine hydrochloridebuprenorphine hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-924buprenorphine hydrochloridebuprenorphine hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-924buprenorphine hydrochloridebuprenorphine hydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-924buprenorphine hydrochloridebuprenorphine hydrochlorideHi-Tech Pharmacal Co., InANDACurrent
50383-924buprenorphine hydrochloridebuprenorphine hydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-924buprenorphine hydrochloridebuprenorphine hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-924buprenorphine hydrochloridebuprenorphine hydrochlorideAkorn Operating Company LLC (dba Akorn)ANDACurrent
50383-924buprenorphine hydrochloridebuprenorphine hydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-930buprenorphine hydrochloridebuprenorphine hydrochlorideHi-Tech Pharmacal Co., InANDACurrent
50383-930buprenorphine hydrochloridebuprenorphine hydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-930buprenorphine hydrochloridebuprenorphine hydrochlorideAkorn Operating Company LLC (dba Akorn)ANDACurrent
50383-930buprenorphine hydrochloridebuprenorphine hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-930buprenorphine hydrochloridebuprenorphine hydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-930buprenorphine hydrochloridebuprenorphine hydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-930buprenorphine hydrochloridebuprenorphine hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-930buprenorphine hydrochloridebuprenorphine hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
53217-246buprenorphine hydrochloridebuprenorphine hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
63629-7125buprenorphine hydrochloridebuprenorphine hydrochlorideBryant Ranch PrepackANDACurrent
63629-7125buprenorphine hydrochloridebuprenorphine hydrochlorideBryant Ranch PrepackANDACurrent
63629-7126buprenorphine hydrochloridebuprenorphine hydrochlorideBryant Ranch PrepackANDACurrent
63629-7126buprenorphine hydrochloridebuprenorphine hydrochlorideBryant Ranch PrepackANDACurrent
64725-0930buprenorphine hydrochloridebuprenorphine hydrochlorideTYA PharmaceuticalsANDACurrent
64725-1924buprenorphine hydrochloridebuprenorphine hydrochlorideTYA PharmaceuticalsANDACurrent
67046-990buprenorphine hydrochloridebuprenorphine hydrochlorideContract Pharmacy Services-PAANDACurrent
67046-991buprenorphine hydrochloridebuprenorphine hydrochlorideContract Pharmacy Services-PAANDACurrent
70518-0442buprenorphine hydrochloridebuprenorphine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2216buprenorphine hydrochloridebuprenorphine hydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24070ORIG2015-07-02