Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202097
Company: KINDEVA
Company: KINDEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENTANYL-100 | FENTANYL | 100MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB | No | No |
| FENTANYL-12 | FENTANYL | 12.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB | No | No |
| FENTANYL-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB | No | No |
| FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB | No | No |
| FENTANYL-75 | FENTANYL | 75MCG/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 |
|---|---|---|---|---|---|---|---|
| 11/04/2016 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2023 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2023 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-4 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/11/2023 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/26/2017 | SUPPL-1 | REMS-Modified |
Label is not available on this site. |
FENTANYL-100
FILM, EXTENDED RELEASE;TRANSDERMAL; 100MCG/HR
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENTANYL-100 | FENTANYL | 100MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 077449 | AVEVA |
| FENTANYL-100 | FENTANYL | 100MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 202097 | KINDEVA |
| FENTANYL-100 | FENTANYL | 100MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 076258 | MYLAN TECHNOLOGIES |
| FENTANYL-100 | FENTANYL | 100MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 077154 | SPECGX LLC |
FENTANYL-12
FILM, EXTENDED RELEASE;TRANSDERMAL; 12.5MCG/HR
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENTANYL-12 | FENTANYL | 12.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 077449 | AVEVA |
| FENTANYL-12 | FENTANYL | 12.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 202097 | KINDEVA |
| FENTANYL-12 | FENTANYL | 12.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 076258 | MYLAN TECHNOLOGIES |
| FENTANYL-12 | FENTANYL | 12.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 077154 | SPECGX LLC |
FENTANYL-25
FILM, EXTENDED RELEASE;TRANSDERMAL; 25MCG/HR
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENTANYL-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 077449 | AVEVA |
| FENTANYL-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 202097 | KINDEVA |
| FENTANYL-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 076258 | MYLAN TECHNOLOGIES |
| FENTANYL-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 077154 | SPECGX LLC |
FENTANYL-50
FILM, EXTENDED RELEASE;TRANSDERMAL; 50MCG/HR
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 077449 | AVEVA |
| FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 202097 | KINDEVA |
| FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 076258 | MYLAN TECHNOLOGIES |
| FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 077154 | SPECGX LLC |
FENTANYL-75
FILM, EXTENDED RELEASE;TRANSDERMAL; 75MCG/HR
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENTANYL-75 | FENTANYL | 75MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 077449 | AVEVA |
| FENTANYL-75 | FENTANYL | 75MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 202097 | KINDEVA |
| FENTANYL-75 | FENTANYL | 75MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 076258 | MYLAN TECHNOLOGIES |
| FENTANYL-75 | FENTANYL | 75MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 077154 | SPECGX LLC |