FDA.reportPublic FDA data

Application 205954

Type
ANDA
Sponsor
ALVOGEN PINE BROOK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEFILM;BUCCAL, SUBLINGUALEQ 2MG BASE;EQ 0.5MG BASENoNo
002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEFILM;BUCCAL, SUBLINGUALEQ 4MG BASE;EQ 1MG BASENoNo
003BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEFILM;BUCCAL, SUBLINGUALEQ 8MG BASE;EQ 2MG BASENoNo
004BUPRENORPHINE 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
47781-355Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-355Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-355Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-355Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-355Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-355Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-355Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-356Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-356Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-356Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-356Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-356Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-356Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-356Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-357Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-357Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-357Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-357Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-357Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-357Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-357Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-358Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-358Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-358Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-358Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-358Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-358Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
47781-358Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlvogen Inc.ANDACurrent
52427-692Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-692Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-692Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-692Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-694Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-694Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-694Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-694Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-698Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-698Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-698Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-698Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-712Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-712Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-712Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent
52427-712Buprenorphine and NaloxoneBuprenorphine and NaloxoneAlmatica Pharma Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76392ORIG 2023-11-06