BUPRENORPHINE از شرکت AMNEAL

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 از شرکت AMNEAL

Abbreviated New Drug Application (ANDA): 211586

Company: AMNEAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPRENORPHINE BUPRENORPHINE 5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription

AB

No No
BUPRENORPHINE BUPRENORPHINE 7.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription

AB

No No
BUPRENORPHINE BUPRENORPHINE 10MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription

AB

No No
BUPRENORPHINE BUPRENORPHINE 15MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription

AB

No No
BUPRENORPHINE BUPRENORPHINE 20MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL 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
04/14/2020 ORIG-1 Approval

STANDARD

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211586Orig1s000ltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/02/2021 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

BUPRENORPHINE

FILM, EXTENDED RELEASE;TRANSDERMAL; 5MCG/HR

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE BUPRENORPHINE 5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 211586 AMNEAL
BUPRENORPHINE BUPRENORPHINE 5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 210162 MYLAN TECHNOLOGIES
BUPRENORPHINE BUPRENORPHINE 5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP

FILM, EXTENDED RELEASE;TRANSDERMAL; 7.5MCG/HR

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE BUPRENORPHINE 7.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 211586 AMNEAL
BUPRENORPHINE BUPRENORPHINE 7.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 210162 MYLAN TECHNOLOGIES
BUPRENORPHINE BUPRENORPHINE 7.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 7.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP

FILM, EXTENDED RELEASE;TRANSDERMAL; 10MCG/HR

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE BUPRENORPHINE 10MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 211586 AMNEAL
BUPRENORPHINE BUPRENORPHINE 10MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 210162 MYLAN TECHNOLOGIES
BUPRENORPHINE BUPRENORPHINE 10MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 10MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP

FILM, EXTENDED RELEASE;TRANSDERMAL; 15MCG/HR

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE BUPRENORPHINE 15MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 211586 AMNEAL
BUPRENORPHINE BUPRENORPHINE 15MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 210162 MYLAN TECHNOLOGIES
BUPRENORPHINE BUPRENORPHINE 15MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 15MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP

FILM, EXTENDED RELEASE;TRANSDERMAL; 20MCG/HR

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE BUPRENORPHINE 20MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 211586 AMNEAL
BUPRENORPHINE BUPRENORPHINE 20MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 210162 MYLAN TECHNOLOGIES
BUPRENORPHINE BUPRENORPHINE 20MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 20MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP
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