Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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Opioid Analgesic REMS
Shared System REMS
REMS last update: 09/18/2018

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
Apadaz (benzhydrocodone and acetaminophen) (Info at Drugs@FDA) NDA 208653 KEMPHARM 09/18/2018
Arymo ER (morphine sulfate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 208603 EGALET 01/09/2017 e60552c9-06ce-4790-95e7-aadd4df12b2a http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=208603
Belbuca (buprenorphine) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 207932 BDSI 10/23/2015 69df676c-0357-4e67-a92d-f6b337b34a2f http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=207932
Butrans (buprenorphine) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 021306 PURDUE PHARMA LP 07/09/2012 794aa355-66de-41b8-aedf-f2c40f6bc664 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=021306
Conzip (tramadol hydrochloride) (Info at Drugs@FDA) NDA 22370 CIPHER PHARMS INC 09/18/2018
Demerol (meperidine hydrochloride) (Info at Drugs@FDA) NDA 5010 US PHARM HOLDINGS 09/18/2018
Demerol (meperidine hydrochloride) (Info at Drugs@FDA) NDA 5010 US PHARM HOLDINGS 09/18/2018
Dilaudid (hydromorphone hydrochloride) (Info at Drugs@FDA) NDA 19891 RHODES PHARMS 09/18/2018
Dilaudid (hydromorphone hydrochloride) (Info at Drugs@FDA) NDA 19892 RHODES PHARMS 09/18/2018
Dolophine (methadone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 006134 WEST-WARD PHARMS INT 07/09/2012 4a3b2bc3-d837-4ca9-aee1-452633b6a06b http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=006134
Duragesic (fentanyl transdermal system) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 019813 JANSSEN PHARMS 07/09/2012 d7aade83-9e69-4cd5-8dab-dbf1d7b89bb4 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=019813
Embeda (morphine sulfate and naltrexone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 022321 ALPHARMA PHARMS 07/09/2012 dfe97a3d-247d-4dda-a641-1a95196cd8d8 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022321
Exalgo (hydromorphone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 021217 SPECGX LLC 07/09/2012 22e635cb-98c0-e4f9-6a71-62d7487a0a6c http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=021217
Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) (Info at Drugs@FDA) NDA 20232 ACTAVIS LABS UT INC 09/18/2018
Fiorinal with Codeine (aspirin, butalbital, caffeine, and codeine phosphate) (Info at Drugs@FDA) NDA 19429 ALLERGAN SALES LLC 09/18/2018
Hysingla ER (hydrocodone bitartrate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 206627 PURDUE PHARMA LP 11/20/2014 b7d23ac2-e776-9f62-3290-c64c2d6eb353 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=206627
Kadian (morphine sulfate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 020616 ALLERGAN SALES LLC 07/09/2012 4598407c-11cc-4f04-8acb-723f97aa16b8 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=020616
Methadose (methadone hydrochloride) ( Info at Drugs@FDA ) ANDA 040050 SPECGX LLC 07/09/2012 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=040050
Morphabond (morphine sulfate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 206544 DAIICHI SANKYO INC 10/02/2015 1806c935-0a76-4f6a-80c8-4aee8a95cb7d http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=206544
MS Contin (morphine sulfate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 019516 PURDUE PHARMA LP 07/09/2012 e0472c35-3f44-42e2-9b75-37b2e9ff65f6 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=019516
Nucynta (tapentadol) (Info at Drugs@FDA) NDA 22304 DEPO NF 09/18/2018
Nucynta (tapentadol hydrochloride) (Info at Drugs@FDA) NDA 203794 DEPOMED INC 09/18/2018
Nucynta ER (tapentadol) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 200533 DEPO NF 07/09/2012 f4c911f3-484b-44fa-833e-2d970d39be8f http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200533
Opana (oxymorphone hydrochloride) (Info at Drugs@FDA) NDA 21611 ENDO PHARMS 09/18/2018
Opana ER (oxymorphone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 201655 ENDO PHARMS 07/09/2012 e6e34c18-fbc6-4cab-9aed-0905d93c2ab6 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=201655
Opana ER (oxymorphone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 021610 ENDO PHARMS 07/09/2012 0ae0e103-5250-4745-8ae2-74fa47fbf973 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=021610
Oxaydo (oxycodone hydrochloride) (Info at Drugs@FDA) NDA 202080 EGALET US INC 09/18/2018
OxyContin (oxycodone hydrochloride) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 022272 PURDUE PHARMA LP 07/09/2012 bfdfe235-d717-4855-a3c8-a13d26dadede http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022272
Percodan (aspirin and oxycodone hydrochloride) (Info at Drugs@FDA) NDA 7337 ENDO PHARMS 09/18/2018
Roxidone (oxycodone hydrochloride) (Info at Drugs@FDA) NDA 21011 SPECGX LLC 09/18/2018
Roxybond (oxycodone hydrochloride) (Info at Drugs@FDA) NDA 209777 DAIICHI SANKYO INC 09/18/2018
Targiniq ER (oxycodone and naloxone hydrochloride) ( Info at Drugs@FDA ) NDA 205777 PURDUE PHARMA LP 07/23/2014 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=205777
Ultracet (tramadol hydrochloride and acetaminophen) (Info at Drugs@FDA) NDA 21123 JANSSEN PHARMS 09/18/2018
Ultram (tramadol hydrochloride) (Info at Drugs@FDA) NDA 20281 JANSSEN PHARMS 09/18/2018
Xartemis XR (oxycodone hydrochloride and acetaminophen) (Info at Drugs@FDA) NDA 204031 MALLINCKRODT INC 09/18/2018
Xtampza (oxycodone) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 208090 COLLEGIUM PHARM INC 04/26/2016 b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=208090
Zohydro ER (hydrocodone) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 202880 PERNIX IRELAND PAIN 10/25/2013 cf68f7fe-30a9-4f1a-a3a4-6352dc436bbe http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202880
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 88627 TEVA 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 88628 TEVA 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 88629 TEVA 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 85868 SUN PHARM INDS LTD 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 87083 SUN PHARM INDS LTD 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 89805 VINTAGE 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 89990 VINTAGE 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 89828 VINTAGE PHARMS 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 040779 AMNEAL PHARMS NY 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 081249 FOSUN PHARMA 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 081250 FOSUN PHARMA 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 87006 WOCKHARDT BIO AG 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 85861 ACTAVIS MID ATLANTIC 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 202800 AUROLIFE PHARMA LLC 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 40119 HI TECH PHARMA 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 85055 JANSSEN PHARMS 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 91238 LANNETT CO INC 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 89450 MIKART 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 87508 PHARM ASSOC 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 89997 WATSON LABS 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 89998 WATSON LABS 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 89999 WATSON LABS 09/18/2018
acetaminophen and codeine phosphate (Info at Drugs@FDA) ANDA 40419 SPECGX LLC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40409 SPECGX LLC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 210211 WES PHARMA INC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40248 WATSON LABS 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 200343 VISTAPHARM 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40838 PHARM ASSOC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40834 PHARM ASSOC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 202935 PAR PHARM 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 205001 PAR PHARM 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 206142 NOVEL LABS INC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 206245 NOVEL LABS INC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40405 SPECGX LLC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40400 SPECGX LLC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 202991 RHODES PHARMS 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 207808 RHODES PHARMS 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40482 MIKART 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40658 MIKART 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40881 MIKART 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40432 MIKART 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40846 MIKART 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 207171 LANNETT CO INC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 207172 LANNETT CO INC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 206470 ACTAVIS LABS FL INC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 206869 AMNEAL PHARMS NY 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 207137 AMNEAL PHARMS 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 209036 ABHAI LLC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 207709 AUROLIFE PHARMA LLC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 203863 EPIC PHARMA LLC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 040736 AMNEAL PHARMS NY 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40894 GENUS LIFESCIENCES 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40655 VINTAGE PHARMS 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40656 VINTAGE PHARMS 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40355 VINTAGE PHARMS 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 209037 ABHAI LLC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 040099 APIL 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 040148 APIL 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 40826 SUN PHARM INDS LTD 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 202214 TRIS PHARMA INC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 206484 UPSHER-SMITH LABS 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 206718 SPECGX LLC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 90415 VINTAGE PHARMS 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 90118 SUN PHARM INDS INC 09/18/2018
acetaminophen and hydrocodone bitartrate (Info at Drugs@FDA) ANDA 201013 AUROLIFE PHARMA LLC 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 201447 ACTAVIS ELIZABETH 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 201972 AUROLIFE PHARMA LLC 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 87003 WEST-WARD PHARMS INT 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 90535 SUN PHARM INDS INC 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 40105 VINTAGE PHARMS 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 040777 AMNEAL PHARMS 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 90734 VINTAGE PHARMS 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 040800 ACTAVIS ELIZABETH 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 207419 ASCENT PHARMS INC 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 207333 LANNETT CO INC 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 40608 MIKART 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 90177 MAYNE PHARMA INC 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 87003 WEST-WARD PHARMS INT 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 201278 RHODES PHARMS 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 204407 NOVEL LABS INC 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 210079 NESHER PHARMS 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 40171 WATSON LABS 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 40535 WATSON LABS 09/18/2018
acetaminophen and oxycodone (Info at Drugs@FDA) ANDA 40545 SPECGX LLC 09/18/2018
acetaminophen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 207510 WES PHARMA INC 09/18/2018
acetaminophen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 40680 SPECGX LLC 09/18/2018
acetaminophen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 87463 SPECGX LLC 09/18/2018
acetaminophen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 89351 WEST-WARD PHARMS INT 09/18/2018
acetaminophen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 207574 CHEMO RESEARCH SL 09/18/2018
acetaminophen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 210644 ABHAI LLC 09/18/2018
acetaminophen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 209385 ELITE LABS INC 09/18/2018
acetaminophen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 85106 VINTAGE PHARMS LLC 09/18/2018
acetaminophen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 203573 VINTAGE PHARMS 09/18/2018
acetaminophen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 89351 WEST-WARD PHARMS INT 09/18/2018
acetaminophen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 202677 ALVOGEN MALTA 09/18/2018
acetaminophen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 90733 VINTAGE PHARMS 09/18/2018
acetaminophen and oxydodone (Info at Drugs@FDA) ANDA 040778 AMNEAL PHARMS NY 09/18/2018
acetaminophen and tramadol hydrochloride (Info at Drugs@FDA) ANDA 77184 SUN PHARM INDS INC 09/18/2018
acetaminophen and tramadol hydrochloride (Info at Drugs@FDA) ANDA 076914 CSPC OUYI PHARM CO 09/18/2018
acetaminophen and tramadol hydrochloride (Info at Drugs@FDA) ANDA 090485 AMNEAL PHARMS 09/18/2018
acetaminophen and tramadol hydrochloride (Info at Drugs@FDA) ANDA 202076 ALKEM LABS LTD 09/18/2018
acetaminophen and tramadol hydrochloride (Info at Drugs@FDA) ANDA 90460 ZYDUS PHARMS USA INC 09/18/2018
acetaminophen and tramadol hydrochloride (Info at Drugs@FDA) ANDA 78778 APOTEX INC 09/18/2018
acetaminophen and tramadol hydrochloride (Info at Drugs@FDA) ANDA 207152 AUROBINDO PHARMA LTD 09/18/2018
acetaminophen and tramadol hydrochloride (Info at Drugs@FDA) ANDA 77858 MYLAN 09/18/2018
acetaminophen and tramadol hydrochloride (Info at Drugs@FDA) ANDA 206885 MACLEODS PHARMS LTD 09/18/2018
acetaminophen and tramadol hydrochloride (Info at Drugs@FDA) ANDA 201952 MICRO LABS LTD INDIA 09/18/2018
acetaminophen and tramadol hydrochloride (Info at Drugs@FDA) ANDA 76475 PAR PHARM 09/18/2018
acetaminophen, butalbital, caffeine, and codeine phosphate (Info at Drugs@FDA) ANDA 76560 NEXGEN PHARMA INC 09/18/2018
acetaminophen, butalbital, caffeine, and codeine phosphate (Info at Drugs@FDA) ANDA 75618 HIKMA INTL PHARMS 09/18/2018
acetaminophen, butalbital, caffeine, and codeine phosphate (Info at Drugs@FDA) ANDA 74911 VALEANT 09/18/2018
acetaminophen, caffeine, and dihydrocodeine bitartrate (Info at Drugs@FDA) ANDA 204209 LARKEN LABS INC 09/18/2018
aspirin and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 91670 MAYNE PHARMA INC 09/18/2018
aspirin and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 40260 SUN PHARM INDUSTRIES 09/18/2018
aspirin and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 090084 ACTAVIS LABS FL INC 09/18/2018
aspirin and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 40255 WATSON LABS 09/18/2018
aspirin, butalbital, caffeine, and codeine (Info at Drugs@FDA) ANDA 75351 VINTAGE PHARMS LLC 09/18/2018
aspirin, butalbital, caffeine, and codeine (Info at Drugs@FDA) ANDA 74359 WATSON LABS 09/18/2018
aspirin, butalbital, caffeine, and codeine (Info at Drugs@FDA) ANDA 74951 STEVENS J 09/18/2018
aspirin, butalbital, caffeine, and codeine phosphate (Info at Drugs@FDA) ANDA 203335 MAYNE PHARMA INC 09/18/2018
aspirin, butalbital, caffeine, and codeine phosphate (Info at Drugs@FDA) ANDA 75231 NEXGEN PHARMA INC 09/18/2018
aspirin, carisoprodol, and codeine phosphate (Info at Drugs@FDA) ANDA 40118 SANDOZ 09/18/2018
aspirin, carisoprodol, and codeine phosphate (Info at Drugs@FDA) ANDA 40860 INGENUS PHARMS NJ 09/18/2018
aspirin, oxycodone hydrochloride, oxycodone terephthalate (Info at Drugs@FDA) ANDA 87794 SUN PHARM INDUSTRIES 09/18/2018
butorphanol tartrate (Info at Drugs@FDA) ANDA 075499 APOTEX INC 09/18/2018
butorphanol tartrate (Info at Drugs@FDA) ANDA 75824 WEST-WARD PHARMS INT 09/18/2018
butorphanol tartrate (Info at Drugs@FDA) ANDA 75759 MYLAN 09/18/2018
butorphanol tartrate (Info at Drugs@FDA) ANDA 75824 WEST-WARD PHARMS INT 09/18/2018
codeine sulfate (Info at Drugs@FDA) ANDA 203046 LANNETT CO INC 09/18/2018
codeine sulfate (Info at Drugs@FDA) NDA 202245 WEST-WARD PHARMS INT 09/18/2018
codeine sulfate (Info at Drugs@FDA) NDA 22402 WEST-WARD PHARMS INT 09/18/2018
fentanyl (Info at Drugs@FDA) ANDA 202097 3M DRUG DELIVERY 09/18/2018
fentanyl transdermal system ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 077154 SPECGX LLC 07/09/2012 67cb9ea4-5adb-4a3a-9568-266b6f472078 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=077154
fentanyl transdermal system ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076709 ACTAVIS LABS UT INC 07/09/2012 9baf2912-9d0f-412a-8fbf-617f6a4f91ed http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076709
fentanyl transdermal system ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 077449 AVEVA 02/14/2013 51ed4fe8-61fd-499d-abf3-d363f4c096e4 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=077449
fentanyl transdermal system ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076258 MYLAN TECHNOLOGIES 07/09/2012 2a2238e9-4b5d-c56d-8663-dd354ff9ae0c http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076258
fentanyl transdermal system ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 077062 MAYNE PHARMA 07/09/2012 245a75e6-3b45-4dc6-bc58-2e33196faca0 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=077062
Fioricet with Codeine (Info at Drugs@FDA) ANDA 75929 VINTAGE PHARMS 09/18/2018
hydrocodone bitartrate and and ibuprofen (Info at Drugs@FDA) ANDA 204575 AUROLIFE PHARMA LLC 09/18/2018
hydrocodone bitartrate and ibuprofen (Info at Drugs@FDA) ANDA 77723 VINTAGE PHARMS 09/18/2018
hydrocodone bitartrate and ibuprofen (Info at Drugs@FDA) ANDA 076604 ACTAVIS LABS FL INC 09/18/2018
hydrocodone bitartrate and ibuprofen (Info at Drugs@FDA) ANDA 076642 AMNEAL PHARMS NY 09/18/2018
hydrocodone bitartrate and ibuprofen (Info at Drugs@FDA) ANDA 91633 SUN PHARM INDS INC 09/18/2018
hydromorphone hydrochloride (Info at Drugs@FDA) ANDA 076723 ELITE LABS 09/18/2018
hydromorphone hydrochloride (Info at Drugs@FDA) ANDA 74597 WEST-WARD PHARMS INT 09/18/2018
hydromorphone hydrochloride (Info at Drugs@FDA) ANDA 74653 WEST-WARD PHARMS INT 09/18/2018
hydromorphone hydrochloride (Info at Drugs@FDA) ANDA 76723 ELITE LABS 09/18/2018
hydromorphone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 202144 ACTAVIS LABS FL INC 05/12/2014 5a717315-250b-4e2d-b315-3ae1b6c337f9 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202144
hydromorphone hydrochloride (Info at Drugs@FDA) ANDA 77471 LANNETT CO INC 09/18/2018
hydromorphone hydrochloride (Info at Drugs@FDA) ANDA 210176 ASCENT PHARMS INC 09/18/2018
hydromorphone hydrochloride (Info at Drugs@FDA) ANDA 210506 ASCENT PHARMS INC 09/18/2018
hydromorphone hydrochloride (Info at Drugs@FDA) ANDA 205814 AUROLIFE PHARMA LLC 09/18/2018
hydromorphone hydrochloride (Info at Drugs@FDA) ANDA 74653 WEST-WARD PHARMS INT 09/18/2018
hydromorphone hydrochloride (Info at Drugs@FDA) ANDA 74597 WEST-WARD PHARMS INT 09/18/2018
hydromorphone hydrochloride (Info at Drugs@FDA) ANDA 76855 SPECGX LLC 09/18/2018
hydromorphone hydrochloride extended-release ( Info at Drugs@FDA ) ANDA 205629 OSMOTICA 07/07/2016 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=205629
hydromorphone hydrochloride extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 204278 PADDOCK LLC 04/06/2015 780a2616-0392-4715-bc50-71799bea1957 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=204278
Ibudone (Info at Drugs@FDA) ANDA 77727 VINTAGE PHARMS 09/18/2018
ibuprofen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 078316 BARR LABS INC 09/18/2018
ibuprofen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 078769 ACTAVIS ELIZABETH 09/18/2018
ibuprofen and oxycodone hydrochloride (Info at Drugs@FDA) ANDA 78394 WATSON LABS 09/18/2018
levorphanol tartrate (Info at Drugs@FDA) ANDA 74278 SENTYNL THERAPS INC 09/18/2018
meperidine hydrochloride (Info at Drugs@FDA) ANDA 40352 SPECGX LLC 09/18/2018
meperidine hydrochloride (Info at Drugs@FDA) ANDA 40110 WEST-WARD PHARMS INT 09/18/2018
meperidine hydrochloride (Info at Drugs@FDA) ANDA 40893 MIKART 09/18/2018
meperidine hydrochloride (Info at Drugs@FDA) ANDA 40331 EPIC PHARMA 09/18/2018
meperidine hydrochloride (Info at Drugs@FDA) ANDA 40110 WEST-WARD PHARMS INT 09/18/2018
meperidine hydrochloride (Info at Drugs@FDA) ANDA 88744 WEST-WARD PHARMS INT 09/18/2018
meperidine hydrochloride (Info at Drugs@FDA) ANDA 040331 EPIC PHARMA 09/18/2018
meperidine hydrochloride (Info at Drugs@FDA) ANDA 40191 VINTAGE PHARMS 09/18/2018
meperidine hydrochloride (Info at Drugs@FDA) ANDA 088639 BARR 09/18/2018
meperidine hydrochloride (Info at Drugs@FDA) ANDA 088640 BARR 09/18/2018
meperidine hydrochloride (Info at Drugs@FDA) ANDA 88744 WEST-WARD PHARMS INT 09/18/2018
meperidine hydrochloride (Info at Drugs@FDA) ANDA 80448 SUN PHARM INDUSTRIES 09/18/2018
meperidine hydrochloride (Info at Drugs@FDA) ANDA 40446 SUN PHARM INDS INC 09/18/2018
meperidine hydrochloride (Info at Drugs@FDA) ANDA 40186 WATSON LABS 09/18/2018
methadone hydrochloride (Methadose) (Info at Drugs@FDA) ANDA 74184 SPECGX LLC 09/18/2018
methadone hydrochloride (Info at Drugs@FDA) ANDA 90707 VISTAPHARM 09/18/2018
methadone hydrochloride (Info at Drugs@FDA) ANDA 208305 SUN PHARM INDUSTRIES 04/02/2018
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 087997 WEST-WARD PHARMS INT 07/09/2012 8C363F90-C378-48AE-ABBC-AEB25C9BF5CB http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=087997
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 087393 WEST-WARD PHARMS INT 07/09/2012 8C363F90-C378-48AE-ABBC-AEB25C9BF5CB http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=087393
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 089897 WEST-WARD PHARMS INT 07/09/2012 E72841BF-364B-49B1-8E69-7E26DDCD2657 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=089897
methadone hydrochloride (Info at Drugs@FDA) ANDA 75082 SANDOZ 09/18/2018
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methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 203502 AUROLIFE PHARMA LLC 08/31/2015 6984eb5a-57a3-4686-bc67-91bc3e7a531e http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203502
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 040517 SPECGX LLC 07/09/2012 eddf7077-02fb-4771-9823-31984f4ff2bb http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=040517
methadone hydrochloride ( Info at Drugs@FDA ) ANDA 040241 SANDOZ 07/09/2012 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=040241
methadone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090635 THEPHARMANETWORK LLC 07/09/2012 aa8e14c1-fbfd-4e4d-b59e-2d4ae1ca815f http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090635
methadone hydrochloride ( Info at Drugs@FDA ) ANDA 090707 VISTAPHARM 11/02/2012 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090707
methadone hydrochloride (Info at Drugs@FDA) ANDA 77142 SPECGX LLC 09/18/2018
Methadose (Info at Drugs@FDA) ANDA 74184 SPECGX LLC 09/18/2018
morphine sulfate (Info at Drugs@FDA) ANDA 206308 RHODES PHARMS 09/18/2018
morphine sulfate (Info at Drugs@FDA) ANDA 206420 RHODES PHARMS 09/18/2018
morphine sulfate (Info at Drugs@FDA) ANDA 201011 NOSTRUM LABS INC 09/18/2018
morphine sulfate (Info at Drugs@FDA) ANDA 201574 PADDOCK LLC 09/18/2018
morphine sulfate (Info at Drugs@FDA) ANDA 206573 PHARM ASSOC 09/18/2018
morphine sulfate (Info at Drugs@FDA) ANDA 205509 ANI PHARMS INC 09/18/2018
morphine sulfate (Info at Drugs@FDA) ANDA 208809 HI-TECH PHARMACAL 09/18/2018
morphine sulfate (Info at Drugs@FDA) ANDA 202309 LANNETT CO INC 09/18/2018
morphine sulfate (Info at Drugs@FDA) ANDA 202310 LANNETT CO INC 09/18/2018
morphine sulfate (Info at Drugs@FDA) ANDA 202348 SPECGX LLC 09/18/2018
morphine sulfate (Info at Drugs@FDA) ANDA 203518 TRIS PHARMA INC 09/18/2018
morphine sulfate (Info at Drugs@FDA) ANDA 203519 TRIS PHARMA INC 09/18/2018
morphine sulfate (Info at Drugs@FDA) NDA 201517 LANNETT CO INC 09/18/2018
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morphine sulfate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 200824 MYLAN PHARMS INC 07/09/2012 ff61d8e8-ea48-43be-828f-de13a9746b5e http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200824
morphine sulfate (Info at Drugs@FDA) ANDA 201947 VISTAPHARM 09/18/2018
morphine sulfate extended release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 202104 UPSHER-SMITH LABS 06/03/2013 97948a8f-7d1b-4614-b11d-e944cf56590b http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202104
morphine sulfate extended release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 200411 IMPAX LABS INC 04/12/2016 f7e9a4b3-a2ee-4f0a-becd-6ef90867332b http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200411
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 203602 NOVEL LABS INC 12/16/2015 e044604d-f210-4411-a6e8-6a9dbdb1a9bd http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203602
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 205634 SUN PHARM INDUSTRIES 08/25/2016 6208902e-4e2f-4b91-8a24-29f122aa7b24 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=205634
morphine sulfate extended-release ( Info at Drugs@FDA ) ANDA 091357 EPIC PHARMA LLC 06/23/2016 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=091357
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 205386 MAYNE PHARMA INC 10/28/2016 053e3fd9-25fc-4b55-b683-63fb9d190dae http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=205386
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 203849 ACTAVIS ELIZABETH 04/06/2015 75fb4282-0bbd-4d63-a7d1-5142780a4fae http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203849
morphine sulfate extended-release ( Info at Drugs@FDA ) ANDA 077855 NESHER PHARMS 05/08/2015 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=077855
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076733 NESHER PHARMS 05/08/2015 7fc20bfa-86c2-40a0-be8e-8f5447bcee44 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076733
morphine sulfate extended-release ( Info at Drugs@FDA ) ANDA 202718 TEVA PHARMS USA 12/29/2014 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202718
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076720 NESHER PHARMS 05/08/2015 1a2c9474-fab6-41a0-844d-d6bd5e6a4341 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076720
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 079040 ACTAVIS ELIZABETH 01/16/2013 2da87bfa-11fd-43e3-8fef-d16ebeb15680 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=079040
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 078761 SUN PHARM INDS LTD 04/15/2013 736c9b80-682c-4cda-bf18-61b18de0bd39 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=078761
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 074769 RHODES PHARMS 07/09/2012 19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=074769
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 074862 RHODES PHARMS 07/09/2012 19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=074862
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076412 SPECGX LLC 07/09/2012 533034fd-c8e7-495b-8874-0db41bd1e65a http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076412
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076438 SPECGX LLC 07/09/2012 533034fd-c8e7-495b-8874-0db41bd1e65a http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076438
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 200812 PAR PHARM INC 04/24/2013 0e56601d-1c78-4258-9106-40c19a92cca8 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200812
morphine sulfate extended-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 075295 VINTAGE PHARMS LLC 07/09/2012 a07378f9-607a-49c6-bdb8-5c8b4ce91a49 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=075295
naloxone and pentazocine (Info at Drugs@FDA) ANDA 74736 WATSON LABS 09/18/2018
naloxone and pentazocine (Info at Drugs@FDA) ANDA 75735 GAVIS PHARMS 09/18/2018
naloxone and petazocine (Info at Drugs@FDA) ANDA 75523 SUN PHARM INDS LTD 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 90659 SUN PHARM INDS INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 208593 ABHAI LLC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 076636 ACTAVIS ELIZABETH 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 77712 VINTAGE PHARMS 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 202773 AVANTHI INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 90985 WOCKHARDT USA 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 91490 RHODES PHARMS 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 90895 EPIC PHARMA LLC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) NDA 200534 GENUS LIFESCIENCES 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) NDA 200535 GENUS LIFESCIENCES 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) NDA 201194 VISTAPHARM 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 091393 AVANTHI INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 202116 ALVOGEN MALTA 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 202160 AUROLIFE PHARMA LLC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 202662 EPIC PHARMA LLC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 203208 WEST-WARD PHARMS INT 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 208795 HI-TECH PHARMACAL 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 207418 ASCENT PHARMS INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 207418 ASCENT PHARMS INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 209021 ASCENT PHARMS INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 203823 LANNETT CO INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 204085 LANNETT CO INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 208817 HI-TECH PHARMACAL 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 207119 NUVO PHARM 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 206456 WOCKHARDT BIO AG 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 204037 WEST-WARD PHARMS INT 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 203447 ANI PHARMS INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 204979 ANI PHARMS INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 205177 ANI PHARMS INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 203638 AMNEAL PHARMS 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 91313 MAYNE PHARMA INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 203107 MAYNE PHARMA INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 204092 MAYNE PHARMA INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 206822 PHARM ASSOC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 204603 NOVEL LABS INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 204752 NOVEL LABS INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 204021 NOVEL LABS INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 77290 NESHER PHARMS 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 91490 RHODES PHARMS 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 76758 SPECGX LLC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 207511 WES PHARMA INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 209897 WES PHARMA INC 09/18/2018
oxycodone hydrochloride (Info at Drugs@FDA) ANDA 202537 VISTAPHARM 09/18/2018
oxymorphone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 079087 IMPAX LABS 10/12/2012 557e9610-62d7-42bf-90c1-44215bd8c1f8 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=079087
oxymorphone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 079046 ACTAVIS ELIZABETH 07/09/2012 468bc2c3-9af3-4db1-b079-f2b5b98e951d http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=079046
oxymorphone hydrochloride (Info at Drugs@FDA) ANDA 202321 SPECGX LLC 09/18/2018
oxymorphone hydrochloride (Info at Drugs@FDA) ANDA 90964 WEST-WARD PHARMS INT 09/18/2018
oxymorphone hydrochloride (Info at Drugs@FDA) ANDA 203601 AVANTHI INC 09/18/2018
oxymorphone hydrochloride (Info at Drugs@FDA) ANDA 204459 AUROLIFE PHARMA LLC 09/18/2018
oxymorphone hydrochloride (Info at Drugs@FDA) ANDA 210175 ASCENT PHARMS INC 09/18/2018
oxymorphone hydrochloride (Info at Drugs@FDA) ANDA 201187 EPIC PHARMA LLC 09/18/2018
oxymorphone hydrochloride (Info at Drugs@FDA) ANDA 90964 WEST-WARD PHARMS INT 09/18/2018
oxymorphone hydrochloride ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 202946 SPECGX LLC 06/27/2014 6e36199a-1536-4cd4-8a04-0cbd0acfb4a5 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202946
oxymorphone hydrochloride (Info at Drugs@FDA) NDA 22207 WEST-WARD PHARMS INT 09/18/2018
oxymorphone hydrochloride (Info at Drugs@FDA) ANDA 91443 TEVA 09/18/2018
oxymorphone hydrochloride extended release ( Info at Drugs@FDA ) ANDA 200822 WEST-WARD PHARMS INT 07/15/2013 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200822
Percocet (Info at Drugs@FDA) ANDA 40330 VINTAGE PHARMS LLC 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 75983 SPECGX LLC 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 091498 CSPC OUYI PHARM CO 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 091609 ACTAVIS ELIZABETH 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 200491 ANCHEN PHARMS 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 75977 TEVA 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 75962 WATSON LABS 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 91607 SUN PHARMA GLOBAL 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 201384 SUN PHARMA GLOBAL 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 76100 SUN PHARM INDUSTRIES 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 75964 SUN PHARM INDS INC 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 075981 APOTEX 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 076003 AMNEAL PHARMS 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 75968 FOSUN PHARMA 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 201973 IPCA LABS LTD 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 200503 LUPIN LTD 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 205702 MACLEODS PHARMS LTD 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 204421 AUROBINDO PHARMA LTD 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 203494 AUROBINDO PHARMA LTD 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 90404 ZYDUS PHARMS USA INC 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 75980 MYLAN PHARMS INC 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 75986 MYLAN 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 205257 MYLAN PHARMS INC 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 75982 PLIVA 09/18/2018
tramadol hydrochloride (Info at Drugs@FDA) ANDA 78783 PAR PHARM INC 09/18/2018

What is the purpose of the REMS?

The goal of the Opioid Analgesic REMS is to educate prescribers and other healthcare providers (including pharmacists and nurses) on the treatment and monitoring of patients with pain. The education provided through the REMS program is based on the Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (“FDA Blueprint”). Through better education, the healthcare team will have an improved understanding of how to manage pain and the role of opioid analgesics along with nonpharmacologic and non-opioid analgesics in pain management. The education will also provide information about the risks of opioids and use of other therapies which is intended to assist healthcare providers in reducing adverse outcomes of addiction, unintentional overdose, and death resulting from inappropriate prescribing, abuse, and misuse. The REMS will accomplish this goal by:

  1. Ensuring that training based on the FDA Blueprint is effective in educating prescribers and other healthcare providers involved in the treatment and monitoring of patients in pain (including pharmacists and nurses) about recommended pain management practices and appropriate use of opioid analgesics.
  2. Informing patients about their roles and responsibilities regarding their pain treatment plan, including the risks of opioid analgesics and how to use and store them safely, as outlined in the Medication Guides and Patient Counseling Guide for opioid analgesics.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare providers who prescribe and healthcare providers involved in the treatment and monitoring of patients who receive opioid analgesics

Receive training provided by the accredited CE provider.
Complete the REMS-compliant training, including the knowledge assessment.

Patients who recieve opioid analgesics

Are informed about their roles and responsibilities regarding their pain treatment plan as outlined in the Medication Guides and Patient Counseling Guide for opioid analgesics.

View additional drug-specific postmarket safety information from the FDA

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Opioid Analgesic REMS REMS, see the DailyMed link on the Products tab.

Material Name Material Name Link
FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain (Blueprint) (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_analgesic_2018_09_18_FDA_Blueprint.pdf
Healthcare Provider Letter 1 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_Healthcare_Provider_Letter_1.pdf
Healthcare Provider Letter 2 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_Healthcare_Provider_Letter_2.pdf
Patient Counseling Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_Patient_Counseling_Guide.pdf
Professional Society Licensing Board Letter 1 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_Professional Society_Licensing_Board_Letter_1.pdf
Professional Society Licensing Board Letter 2 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_Professional Society_Licensing_Board_Letter_2.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_REMS_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18__REMS_Website_Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
09/18/2018

REMS name changed to Opioid Analgesic REMS. REMS modified to:

  1. Include immediate-release (IR) opioid analgesics intended for use in an outpatient setting
  2. Ensure that training is made available to healthcare providers involved in the treatment and monitoring of patients with pain (including nurses and pharmacists)
  3. Implement an updated FDA Blueprint for Healthcare Provider (HCP) Education which requires the education to cover broader information about appropriate pain management.
05/26/2017 Modified to align the REMS document and materials with the labeling approved on December 16, 2016, as well as additional minor modifications.
09/30/2016 Modified to relocate the product-specific information section from the Blueprint for Prescriber Education to the FDA website located at http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM515636.pdf.
08/19/2016 Modified to add Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) product information to the shared system REMS.
04/26/2016 Modified to add Xtampza ER (oxycodone) product information to the shared system REMS.
04/20/2016 Modified to include the following information in the ER/LA Opioid Analgesics REMS Blueprint for Prescriber Education:

  1. Incorporate information regarding the use of OxyContin in the pediatric population.
  2. Add information to the titration recommendations of OxyContin for adult patients.
  3. Add product-specific information for a recently approved ER/LA opioid analgesic, MorphaBond (morphine sulfate extended release) tablets.
  4. Add product-specific information for a recently approved ER/LA opioid analgesic, Belbuca (buprenorphine) buccal film.
10/23/2015 Modified to add the Belbuca (buprenorphine), product to the shared system REMS.
10/02/2015 Modified to add the Morphabond (morphine sulfate) product to the shared system REMS.
08/13/2015 Modified to:

  1. Incorporate information regarding use of OXYCONTIN in the pediatric population
  2. Add information to the titration recommendations for adult patients.
06/26/2015 Modified to:

  1. Change the ER/LA Opioid Analgesics REMS Blueprint for Prescriber Education to incorporate:
    1. Product-specific information for a recently approved ER/LA opioid analgesic, Hysingla ER (hydrocodone bitartrate extended-release) tablets.
    2. Newly approved intermediate strengths of fentanyl transdermal systems.
    3. Revised titration information for Dolophine (methadone HCl tablets).
12/29/2014 Modified to add three new dosage strengths for fentanyl transdermal system [ANDA 076258].
11/20/2014 Modified to add the Hysingla ER product to the shared system REMS.
08/19/2014 Modified to:

  1. Incorporate the following safety labeling changes to the ER/LA Opioid Analgesics REMS Blueprint, ER/LA opioid analgesic REMS Website, and the Dear Prescriber Letter (DHCP) letter:
    1. New indication for ER/LA opioid analgesics.
    2. New warning for Neonatal Opioid Withdraw Syndrome (NOWS).
    3. Updated language for the following Warnings and Precautions:
      1. Addiction, Abuse, and Misuse
      2. Life-Threatening Respiratory Depression
      3. Accidental Ingestion
      4. Cytochrome P450 3A4 Interaction (for applicable products)
    4. Revisions to the Blueprint to incorporate updated product-specific titration language.
  2. Change the ER/LA Opioid Analgesics REMS Blueprint to include product-specific information for ER/LA opioids approved after the last ER/LA REMS modification on April 15, 2013
07/23/2014 Modified to add the Targiniq ER product to the shared system REMS.
06/30/2014 Modified to add the 7.5 mcg/hour intermediate dosage strength [to the Butrans (buprenorphine) Transdermal System] to the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics.
10/25/2013 Modified to add the Zohydro product to the shared system REMS.
04/15/2013 Modified to:
  1. Revise Section VI. Specific Drug information for ER/LA Opioid Analgesic Products of the FDA Blueprint.
  2. Revise the REMS Website, including the landing page and the webpage listing covered products under the REMS program.
  3. Revise the individual product Medication Guides for relevant drugs.
  4. Revise the REMS document to remove ANDA holders from the Timetable for Submission of Assessments.
08/28/2012 Modified to:
  1. Add Nucynta ER REMS product information to the shared system.
  2. Make technical corrections to the Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics (FDA Blueprint).
07/09/2012 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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