FDA.reportPublic FDA data

Application 201066

Type
ANDA
Sponsor
MYLAN

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
0378-0923Buprenorphine Hydrochloride Sublingualbuprenorphine hydrochloride sublingualMylan Pharmaceuticals Inc.ANDACurrent
0378-0923Buprenorphine Hydrochloride Sublingualbuprenorphine hydrochloride sublingualMylan Pharmaceuticals Inc.ANDACurrent
0378-0924Buprenorphine Hydrochloride Sublingualbuprenorphine hydrochloride sublingualMylan Pharmaceuticals Inc.ANDACurrent
0378-0924Buprenorphine Hydrochloride Sublingualbuprenorphine hydrochloride sublingualMylan Pharmaceuticals Inc.ANDACurrent
67046-996Buprenorphine Hydrochloride Sublingualbuprenorphine hydrochloride sublingualContract Pharmacy Services-PAANDACurrent
67046-997Buprenorphine Hydrochloride Sublingualbuprenorphine hydrochloride sublingualContract Pharmacy Services-PAANDACurrent
70518-0652Buprenorphine Hydrochloride Sublingualbuprenorphine hydrochloride sublingualREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44573ORIG2015-07-02