Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211594
Company: ALVOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.075MG BASE FILM;BUCCAL Prescription AB No No
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.15MG BASE FILM;BUCCAL Prescription AB No No
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE FILM;BUCCAL Prescription AB No No
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.45MG BASE FILM;BUCCAL Prescription AB No No
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.6MG BASE FILM;BUCCAL Prescription AB No No
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.75MG BASE FILM;BUCCAL Prescription AB No No
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.9MG BASE FILM;BUCCAL 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
08/03/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211594Orig1s000ltr.pdf

BUPRENORPHINE HYDROCHLORIDE

FILM;BUCCAL; EQ 0.075MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BELBUCA BUPRENORPHINE HYDROCHLORIDE EQ 0.075MG BASE FILM;BUCCAL Prescription Yes AB 207932 BDSI
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.075MG BASE FILM;BUCCAL Prescription No AB 211594 ALVOGEN

FILM;BUCCAL; EQ 0.15MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BELBUCA BUPRENORPHINE HYDROCHLORIDE EQ 0.15MG BASE FILM;BUCCAL Prescription Yes AB 207932 BDSI
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.15MG BASE FILM;BUCCAL Prescription No AB 211594 ALVOGEN

FILM;BUCCAL; EQ 0.3MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BELBUCA BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE FILM;BUCCAL Prescription Yes AB 207932 BDSI
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE FILM;BUCCAL Prescription No AB 211594 ALVOGEN

FILM;BUCCAL; EQ 0.45MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BELBUCA BUPRENORPHINE HYDROCHLORIDE EQ 0.45MG BASE FILM;BUCCAL Prescription Yes AB 207932 BDSI
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.45MG BASE FILM;BUCCAL Prescription No AB 211594 ALVOGEN

FILM;BUCCAL; EQ 0.6MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BELBUCA BUPRENORPHINE HYDROCHLORIDE EQ 0.6MG BASE FILM;BUCCAL Prescription Yes AB 207932 BDSI
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.6MG BASE FILM;BUCCAL Prescription No AB 211594 ALVOGEN

FILM;BUCCAL; EQ 0.75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BELBUCA BUPRENORPHINE HYDROCHLORIDE EQ 0.75MG BASE FILM;BUCCAL Prescription Yes AB 207932 BDSI
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.75MG BASE FILM;BUCCAL Prescription No AB 211594 ALVOGEN

FILM;BUCCAL; EQ 0.9MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BELBUCA BUPRENORPHINE HYDROCHLORIDE EQ 0.9MG BASE FILM;BUCCAL Prescription Yes AB 207932 BDSI
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.9MG BASE FILM;BUCCAL Prescription No AB 211594 ALVOGEN

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