Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205299
Company: DR REDDYS LABS SA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE FILM;BUCCAL, SUBLINGUAL Prescription AB No No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE FILM;BUCCAL, SUBLINGUAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/14/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205299Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2018 SUPPL-1 REMS - MODIFIED - D-N-A

Label is not available on this site.

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

FILM;BUCCAL, SUBLINGUAL; EQ 2MG BASE;EQ 0.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 205954 ALVOGEN PINE BROOK
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 205299 DR REDDYS LABS SA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 211785 MYLAN TECHNOLOGIES
SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE FILM;BUCCAL, SUBLINGUAL Prescription Yes AB 022410 INDIVIOR INC

FILM;BUCCAL, SUBLINGUAL; EQ 8MG BASE;EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 205954 ALVOGEN PINE BROOK
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 205299 DR REDDYS LABS SA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 207607 MYLAN TECHNOLOGIES
SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE FILM;BUCCAL, SUBLINGUAL Prescription Yes AB 022410 INDIVIOR INC

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