Drugs@FDA: FDA-Approved Drugs
Company: MYLAN TECHNOLOGIES
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-37 | FENTANYL | 37.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB | No | No |
FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB | No | No |
FENTANYL-62 | FENTANYL | 62.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB | No | No |
FENTANYL-75 | FENTANYL | 75MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB | No | No |
FENTANYL-87 | FENTANYL | 87.5MCG/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 |
---|---|---|---|---|---|---|---|
01/28/2005 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76-258.rescind.ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076258ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076258.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-46 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
12/14/2023 | SUPPL-43 | Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
||
09/18/2018 | SUPPL-37 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
05/26/2017 | SUPPL-35 | REMS-Modified |
Label is not available on this site. |
||
09/30/2016 | SUPPL-33 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
04/20/2016 | SUPPL-32 | REMS-Modified |
Label is not available on this site. |
||
06/26/2015 | SUPPL-31 | REMS-Modified |
Label is not available on this site. |
||
08/19/2014 | SUPPL-30 | REMS-Modified |
Label is not available on this site. |
||
06/20/2014 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
07/08/2015 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
04/15/2013 | SUPPL-22 | REMS-Modified |
Label is not available on this site. |
||
07/09/2012 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
07/09/2012 | SUPPL-19 | REMS-Proposal |
Label is not available on this site. |
||
07/10/2012 | SUPPL-18 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
05/20/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
09/06/2005 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
01/23/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
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01/23/2007 | SUPPL-5 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
05/04/2005 | SUPPL-2 | Labeling |
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-37
FILM, EXTENDED RELEASE;TRANSDERMAL; 37.5MCG/HR
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FENTANYL-37 | FENTANYL | 37.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 077449 | AVEVA |
FENTANYL-37 | FENTANYL | 37.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 076258 | MYLAN TECHNOLOGIES |
FENTANYL-37 | FENTANYL | 37.5MCG/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-62
FILM, EXTENDED RELEASE;TRANSDERMAL; 62.5MCG/HR
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FENTANYL-62 | FENTANYL | 62.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 077449 | AVEVA |
FENTANYL-62 | FENTANYL | 62.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 076258 | MYLAN TECHNOLOGIES |
FENTANYL-62 | FENTANYL | 62.5MCG/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 |
FENTANYL-87
FILM, EXTENDED RELEASE;TRANSDERMAL; 87.5MCG/HR
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FENTANYL-87 | FENTANYL | 87.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 077449 | AVEVA |
FENTANYL-87 | FENTANYL | 87.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB | 076258 | MYLAN TECHNOLOGIES |