Drugs@FDA: FDA-Approved Drugs

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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

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 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
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 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 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 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 20MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP

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