FDA.reportPublic FDA data

Application 205806

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 4MG BASE;EQ 1MG 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
43598-580Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-580Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-580Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-580Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-580Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-581Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-581Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-581Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-581Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent
43598-581Buprenorphine and NaloxoneBuprenorphine and NaloxoneDr.Reddys Laboratories IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76377ORIG 2023-11-06
54626ORIG2018-06-20