BUPRENORPHINE HYDROCHLORIDE از شرکت ALVOGEN

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

BUPRENORPHINE HYDROCHLORIDE از شرکت ALVOGEN

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/2021/211594Orig1s000TA_ltr.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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