Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211586
Company: AMNEAL
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 |
|---|---|---|---|---|---|
| 05/30/2024 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-14 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 05/30/2024 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/30/2024 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 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 | 207490 | ALVOGEN |
| BUPRENORPHINE | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 211586 | AMNEAL |
| BUPRENORPHINE | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 210272 | DIFGEN PHARMS |
| 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 | 210272 | DIFGEN PHARMS |
| 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 | 207490 | ALVOGEN |
| BUPRENORPHINE | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 211586 | AMNEAL |
| BUPRENORPHINE | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 210272 | DIFGEN PHARMS |
| 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 | 207490 | ALVOGEN |
| BUPRENORPHINE | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 211586 | AMNEAL |
| BUPRENORPHINE | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 210272 | DIFGEN PHARMS |
| 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 | 207490 | ALVOGEN |
| BUPRENORPHINE | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 211586 | AMNEAL |
| BUPRENORPHINE | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 210272 | DIFGEN PHARMS |
| 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 |