Approved Risk Evaluation and Mitigation Strategies (REMS)
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The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.
The table below provides links to currently approved individual and shared system REMS.
Information on historical and released REMS is available in downloadable: data files.
| Name | REMS Approved | Last Updated | MedGuide (MG)* | Comm. Plan (CP) | ETASU | Imp. System (IS) | |
|---|---|---|---|---|---|---|---|
|
Adasuve
(loxapine),
aerosol, powder
NDA #022549 |
loxapine, | 12/21/2012 | 10/10/2017 |
IS
|
|||
|
Addyi
(flibanserin),
tablet
NDA #022526 |
flibanserin, | 08/18/2015 | 06/16/2017 |
IS
|
|||
|
Adempas
(riociguat),
tablet, film coated
NDA #204819 |
riociguat, | 10/08/2013 | 01/17/2017 |
MG
|
IS
|
||
|
Afrezza
(insulin human),
powder, metered
NDA #022472 |
insulin human, | 06/27/2014 | 04/01/2016 | ||||
|
Alosetron Shared System REMS |
alosetron,alosetron, | 11/22/2016 | 11/22/2016 | ||||
|
Androgel 1%
(testosterone),
gel
NDA #021015 |
testosterone, | 09/18/2009 | 05/11/2015 |
MG
|
|||
|
Androgel 1.62%
(testosterone),
gel
NDA #022309 |
testosterone, | 04/29/2011 | 05/11/2015 |
MG
|
|||
|
Aveed
(testosterone undecanoate),
injection
NDA #022219 |
testosterone undecanoate, | 03/05/2014 | 12/09/2016 |
IS
|
|||
|
Axiron
(testosterone),
solution
NDA #022504 |
testosterone, | 11/23/2010 | 07/13/2017 |
MG
|
|||
|
Blincyto
(blinatumomab),
kit
BLA #125557 |
blinatumomab, | 12/03/2014 | 07/12/2017 | ||||
|
Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) Shared System REMS |
buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine and naloxone,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate,buprenorphine hydrochloride and naloxone hydrochloride dihydrate, | 02/22/2013 | 05/23/2017 |
MG
|
IS
|
||
|
Bupropion (ANDA 206122)
(bupropion hydrochloride),
tablet, extended release
ANDA #206122 |
bupropion hydrochloride, | 08/17/2016 | 08/17/2016 |
MG
|
|||
|
Caprelsa
(vandetanib),
tablet
NDA #022405 |
vandetanib, | 04/06/2011 | 05/16/2017 |
IS
|
|||
|
Clozapine Shared System REMS |
clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine,clozapine, | 09/15/2015 | 09/15/2015 |
IS
|
|||
|
Emtricitabine/tenofovir disoproxil fumarate Shared System REMS |
emtricitabine and tenofovir disoproxil fumarate,emtricitabine and tenofovir disoproxil fumarate, | 07/16/2012 | 12/08/2017 | ||||
|
Entereg
(alvimopan),
capsule
NDA #021775 |
alvimopan, | 05/20/2008 | 06/01/2016 |
IS
|
|||
|
Extended-Release and Long-Acting (ER/LA) Opioid Analgesics Shared System REMS |
buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,buprenorphine,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,fentanyl transdermal system,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydrocodone bitartrate extended-release,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,hydromorphone hydrochloride extended-release,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,methadone hydrochloride,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate and naltrexone hydrochloride,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,morphine sulfate extended-release,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone and naloxone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxycodone hydrochloride and naloxone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,oxymorphone hydrochloride extended-release,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol,tapentadol, | 07/09/2012 | 05/26/2017 |
MG
|
|||
|
Extraneal
(icodextrin),
injection, solution
NDA #021321 |
icodextrin, | 03/09/2011 | 10/24/2016 |
MG
|
IS
|
||
|
Farydak
(panobinostat),
capsule
NDA #205353 |
panobinostat, | 02/23/2015 | 02/23/2015 | ||||
|
Fortesta
(testosterone),
gel, metered
NDA #021463 |
testosterone, | 12/29/2010 | 05/11/2015 |
MG
|
|||
|
Gattex
(teduglutide [rDNA origin]),
injection, powder, for solution
NDA #203441 |
teduglutide [rDNA origin], | 12/21/2012 | 03/21/2017 | ||||
|
Iclusig
(ponatinib),
tablet, film coated
NDA #203469 |
ponatinib, | 12/20/2013 | 11/28/2016 | ||||
|
Ionsys
(fentanyl iontophoretic transdermal system),
patch
NDA #021338 |
fentanyl iontophoretic transdermal system, | 04/30/2015 | 03/29/2017 |
IS
|
|||
|
Isotretinoin iPLEDGE Shared System REMS |
isotretinoin,isotretinoin,isotretinoin,isotretinoin,isotretinoin,isotretinoin,isotretinoin,isotretinoin,isotretinoin,isotretinoin, | 10/22/2010 | 06/17/2017 |
MG
|
IS
|
||
|
Juxtapid
(lomitapide),
capsule
NDA #203858 |
lomitapide, | 12/21/2012 | 03/02/2017 |
IS
|
|||
|
Kymriah
(tisagenlecleucel),
suspension, for intravenous infusion
BLA #125646 |
tisagenlecleucel, | 08/30/2017 | 08/30/2017 |
IS
|
|||
|
Kynamro
(mipomersen sodium),
injection, solution
NDA #203568 |
mipomersen sodium, | 01/29/2013 | 10/25/2017 |
IS
|
|||
|
Lemtrada
(alemtuzumab),
injection, solution, concentrate
BLA #103948 |
alemtuzumab, | 11/14/2014 | 04/05/2016 |
IS
|
|||
|
Letairis
(ambrisentan),
tablet, film coated
NDA #022081 |
ambrisentan, | 05/29/2009 | 09/27/2017 |
MG
|
IS
|
||
|
Lotronex
(alosetron hydrochloride),
tablet
NDA #021107 |
alosetron hydrochloride, | 09/02/2010 | 04/29/2016 | ||||
|
Mifeprex
(mifepristone),
tablet
NDA #020687 |
mifepristone, | 06/08/2011 | 03/29/2016 |
IS
|
|||
|
Myalept
(metreleptin),
injection, powder, lyophilized, for solution
BLA #125390 |
metreleptin, | 02/24/2014 | 12/11/2017 |
IS
|
|||
|
Mycophenolate Shared System REMS |
mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate acid delayed-release tablets,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil capsules,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil for injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil injection,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil oral suspension,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolate mofetil tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed release tablets,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release,mycophenolic acid delayed-release, | 09/25/2012 | 11/13/2015 | ||||
|
Natpara
(parathyroid hormone),
injection, powder, lyophilized, for solution
BLA #125511 |
parathyroid hormone, | 01/23/2015 | 08/04/2017 |
IS
|
|||
|
Nplate
(romiplostim),
injection, powder, lyophilized, for solution
BLA #125268 |
romiplostim, | 08/22/2008 | 12/06/2011 | ||||
|
Omontys
(peginesatide),
injection
NDA #202799 |
peginesatide, | 03/27/2012 | 03/27/2012 | ||||
|
Opsumit
(macitentan),
tablet, film coated
NDA #204410 |
macitentan, | 10/18/2013 | 08/25/2017 |
MG
|
IS
|
||
|
Pomalyst
(pomalidomide),
capsule
NDA #204026 |
pomalidomide, | 02/08/2013 | 06/27/2017 |
IS
|
|||
|
Probuphine
(buprenorphine hydrochloride),
implant
NDA #204442 |
buprenorphine hydrochloride, | 05/26/2016 | 04/19/2017 |
MG
|
IS
|
||
|
Prolia
(denosumab),
injection
BLA #125320 |
denosumab, | 06/01/2010 | 05/21/2015 |
MG
|
|||
|
Qsymia
(phentermine and topiramate),
capsule, extended release
NDA #022580 |
phentermine and topiramate, | 07/17/2012 | 07/03/2017 |
MG
|
IS
|
||
|
Revlimid
(lenalidomide),
capsule
NDA #021880 |
lenalidomide, | 08/03/2010 | 06/27/2017 |
IS
|
|||
|
Saxenda
(liraglutide),
injection, solution
NDA #206321 |
liraglutide, | 12/23/2014 | 05/22/2017 | ||||
|
Siliq
(brodalumab),
injection
BLA #761032 |
brodalumab, | 02/15/2017 | 06/08/2017 |
IS
|
|||
|
Sodium Oxybate Shared System REMS |
sodium oxybate, | 01/17/2017 | 01/17/2017 |
MG
|
IS
|
||
|
Soliris
(eculizumab),
injection, solution, concentrate
BLA #125166 |
eculizumab, | 06/04/2010 | 10/23/2017 |
MG
|
|||
|
Sublocade
(buprenorphine extended-release),
injection
NDA #209819 |
buprenorphine extended-release, | 11/30/2017 | 11/30/2017 |
IS
|
|||
|
Suboxone/Subutex
(buprenorphine and naloxone/buprenorphine),
film, soluble;
tablet
NDA #022410 NDA #020732 NDA #020733 |
buprenorphine and naloxone/buprenorphine,buprenorphine and naloxone/buprenorphine,buprenorphine and naloxone/buprenorphine, | 08/30/2010 | 09/19/2017 |
MG
|
IS
|
||
|
Tanzeum
(albiglutide),
injection, powder, lyophilized, for solution
BLA #125431 |
albiglutide, | 04/15/2014 | 07/27/2015 | ||||
|
Testim
(testosterone),
gel
NDA #021454 |
testosterone, | 09/18/2009 | 05/11/2015 |
MG
|
|||
|
testosterone (ANDA 076744)
(testosterone),
gel
ANDA #076744 |
testosterone, | 09/25/2015 | 09/25/2015 |
MG
|
|||
|
testosterone (ANDA 204255)
(testosterone),
solution
ANDA #204255 |
testosterone, | 02/28/2017 | 02/28/2017 |
MG
|
|||
|
testosterone (ANDA 204571)
(testosterone),
gel, metered
ANDA #204571 |
testosterone, | 08/05/2015 | 08/05/2015 |
MG
|
|||
|
testosterone (ANDA 205328)
(testosterone),
solution
ANDA #205328 |
testosterone, | 08/07/2017 | 08/07/2017 |
MG
|
|||
|
testosterone (ANDA 208061)
(testosterone),
solution
ANDA #208061 |
testosterone, | 10/23/2017 | 10/23/2017 |
MG
|
|||
|
testosterone (NDA 202763)
(testosterone),
gel
NDA #202763 |
testosterone, | 02/14/2012 | 07/01/2015 |
MG
|
|||
|
testosterone (NDA 203098)
(testosterone),
gel
NDA #203098 |
testosterone, | 01/31/2013 | 05/11/2015 |
MG
|
|||
|
testosterone 1% (ANDA 076737)
(testosterone),
gel
ANDA #076737 |
testosterone, | 11/05/2015 | 11/05/2015 |
MG
|
|||
|
testosterone 1% (ANDA 091073)
(testosterone),
gel
ANDA #091073 |
testosterone, | 09/18/2017 | 09/18/2017 |
MG
|
|||
|
testosterone 1.62% (ANDA 204268)
(testosterone),
gel
ANDA #204268 |
testosterone, | 08/04/2015 | 08/04/2015 |
MG
|
|||
|
testosterone 1.62% (ANDA 205781)
(testosterone),
gel
ANDA #205781 |
testosterone, | 07/12/2017 | 07/12/2017 |
MG
|
|||
|
Thalomid
(thalidomide),
capsule
NDA #020785 |
thalidomide, | 08/03/2010 | 06/27/2017 |
IS
|
|||
|
Tracleer
(bosentan),
tablet, dispersible;
tablet, film coated
NDA #021290 NDA #209279 |
bosentan,bosentan, | 08/07/2009 | 10/20/2017 |
MG
|
IS
|
||
|
Transmucosal Immediate-Release Fentanyl (TIRF) Products Shared System REMS |
fentanyl,fentanyl,fentanyl,fentanyl,fentanyl,fentanyl,fentanyl,fentanyl,fentanyl,fentanyl,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl buccal,fentanyl citrate,fentanyl citrate,fentanyl citrate,fentanyl citrate,fentanyl citrate,fentanyl citrate,fentanyl citrate,fentanyl citrate,fentanyl citrate,fentanyl citrate, | 12/28/2011 | 09/07/2017 |
MG
|
IS
|
||
|
Trulicity
(dulaglutide),
injection, solution
BLA #125469 |
dulaglutide, | 09/18/2014 | 04/19/2017 | ||||
|
Tysabri
(natalizumab),
injection
BLA #125104 |
natalizumab, | 10/07/2011 | 10/14/2016 |
MG
|
IS
|
||
|
Vigabatrin Shared System REMS |
vigabatrin,vigabatrin,vigabatrin, | 04/27/2017 | 10/23/2017 |
IS
|
|||
|
Vivitrol
(naltrexone),
kit
NDA #021897 |
naltrexone, | 03/22/2010 | 05/17/2016 |
MG
|
|||
|
Vogelxo
(testosterone),
gel
NDA #204399 |
testosterone, | 06/04/2014 | 08/11/2017 |
MG
|
|||
|
Xiaflex
(collagenase clostridium histolyticum),
kit
BLA #125338 |
collagenase clostridium histolyticum, | 02/02/2010 | 01/25/2017 |
IS
|
|||
|
Xultophy
(insulin degludec and liraglutide injection),
injection
NDA #208583 |
insulin degludec and liraglutide injection, | 11/21/2016 | 11/21/2016 | ||||
|
Xyrem
(Sodium oxybate),
solution
NDA #021196 |
Sodium oxybate, | 02/27/2015 | 07/15/2015 |
MG
|
IS
|
||
|
Yescarta
(axicabtagene ciloleucel),
suspension, for intravenous infusion
BLA #125643 |
axicabtagene ciloleucel, | 10/18/2017 | 10/18/2017 |
IS
|
|||
|
Zinbryta
(daclizumab),
injection
BLA #761029 |
daclizumab, | 05/27/2016 | 11/01/2017 |
IS
|
|||
|
Zydelig
(idelalisib),
tablet, film coated
NDA #205858 NDA #206545 |
idelalisib,idelalisib, | 07/23/2014 | 01/04/2017 | ||||
|
Zyprexa Relprevv
(olanzapine),
kit
NDA #022173 |
olanzapine, | 12/11/2009 | 11/30/2017 |
MG
|
IS
|
*Many products within these REMS programs have Medication Guides not part of the REMS program. For a full list of Medication Guides click here.
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