BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE از شرکت LANNETT CO INC

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 LANNETT CO INC

Abbreviated New Drug Application (ANDA): 205022

Company: LANNETT CO INC

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 TABLET;SUBLINGUAL Prescription

AB

No No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;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
09/19/2016 ORIG-1 Approval

STANDARD

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205022Orig1s000ltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/19/2021 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/08/2019 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert

Label is not available on this site.

10/31/2018 SUPPL-4 REMS – MODIFIED – D-N-A

Label is not available on this site.

02/01/2018 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/01/2018 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/23/2017 SUPPL-1 REMS-Modified

Label is not available on this site.

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

TABLET;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 TABLET;SUBLINGUAL Prescription No AB 091422 ACTAVIS ELIZABETH
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 214930 ALKEM LABS LTD
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 203136 AMNEAL PHARMS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 204431 ETHYPHARM USA CORP
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 203326 HIKMA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 205022 LANNETT CO INC
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 205601 RHODES PHARMS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 207000 SPECGX LLC
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 201633 SUN PHARM
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Prescription No AB 209069 WES PHARMA INC

TABLET;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 TABLET;SUBLINGUAL Prescription No AB 091422 ACTAVIS ELIZABETH
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 214930 ALKEM LABS LTD
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 203136 AMNEAL PHARMS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 204431 ETHYPHARM USA CORP
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 203326 HIKMA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 205022 LANNETT CO INC
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 205601 RHODES PHARMS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 207000 SPECGX LLC
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 201633 SUN PHARM
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Prescription No AB 209069 WES PHARMA INC
بخوانید  BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE از شرکت SPECGX LLC
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