FDA.reportPublic FDA data

Application 207607

Type
ANDA
Sponsor
MYLAN TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEFILM;BUCCAL, SUBLINGUALEQ 8MG BASE;EQ 2MG BASENoNo
002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEFILM;BUCCAL, SUBLINGUALEQ 12MG BASE;EQ 3MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-8767Buprenorphine and Naloxonebuprenorphine and naloxoneMylan Pharmaceuticals Inc.ANDACurrent
0378-8767Buprenorphine and NaloxoneBuprenorphine and NaloxoneMylan Pharmaceuticals Inc.ANDACurrent
0378-8767Buprenorphine and NaloxoneBuprenorphine and NaloxoneMylan Pharmaceuticals Inc.ANDACurrent
0378-8767Buprenorphine and Naloxonebuprenorphine and naloxoneMylan Pharmaceuticals Inc.ANDACurrent
0378-8767Buprenorphine and Naloxonebuprenorphine and naloxoneMylan Pharmaceuticals Inc.ANDACurrent
0378-8768Buprenorphine and Naloxonebuprenorphine and naloxoneMylan Pharmaceuticals Inc.ANDACurrent
0378-8768Buprenorphine and NaloxoneBuprenorphine and NaloxoneMylan Pharmaceuticals Inc.ANDACurrent
0378-8768Buprenorphine and NaloxoneBuprenorphine and NaloxoneMylan Pharmaceuticals Inc.ANDACurrent
0378-8768Buprenorphine and Naloxonebuprenorphine and naloxoneMylan Pharmaceuticals Inc.ANDACurrent
0378-8768Buprenorphine and Naloxonebuprenorphine and naloxoneMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76386ORIG 2023-11-06
54727ORIG2018-06-20
54624ORIG2018-06-20