Application 090360

Type
ANDA
Sponsor
BARR

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
67046-994BuprenorphineBuprenorphineContract Pharmacy Services-PAANDACurrent
67046-995BuprenorphineBuprenorphineContract Pharmacy Services-PAANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44550ORIG2015-07-02