BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE از شرکت MYLAN TECHNOLOGIES

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 AND NALOXONE HYDROCHLORIDE از شرکت MYLAN TECHNOLOGIES

Abbreviated New Drug Application (ANDA): 207607

Company: MYLAN TECHNOLOGIES

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE FILM;BUCCAL, SUBLINGUAL Prescription

AB

No No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 12MG BASE;EQ 3MG 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-2 Approval

STANDARD

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207607Orig1s001ltr_2.pdf

06/14/2018 ORIG-1 Approval

STANDARD

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207607Orig1s000Ltr.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 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

FILM;BUCCAL, SUBLINGUAL; EQ 12MG BASE;EQ 3MG 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 12MG BASE;EQ 3MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 205954 ALVOGEN PINE BROOK
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 12MG BASE;EQ 3MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 205806 DR REDDYS LABS SA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 12MG BASE;EQ 3MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 207607 MYLAN TECHNOLOGIES
SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 12MG BASE;EQ 3MG BASE FILM;BUCCAL, SUBLINGUAL Prescription Yes AB 022410 INDIVIOR INC
بخوانید  BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE از شرکت AMNEAL PHARMS
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