FDA.reportPublic FDA data

Application 205299

Type
ANDA
Sponsor
DR REDDYS LABS SA

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 8MG BASE;EQ 2MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-579Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-579Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-579Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-579Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-582Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-582Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-582Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-582Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76378ORIG 2023-11-06
54627ORIG2018-06-20