Documents
Application Sponsors
| NDA 020903 | MERCK SHARP DOHME | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy** | 0 | REBETOL | RIBAVIRIN |
| 002 | CAPSULE;ORAL | 200MG | 1 | REBETOL | RIBAVIRIN |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1998-06-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 1998-12-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2000-03-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 2000-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2001-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2001-03-13 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2001-03-13 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2001-07-25 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2001-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2001-07-25 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2001-07-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2001-12-28 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2001-10-24 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2002-02-21 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2001-07-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2001-11-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2001-08-29 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2002-03-06 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2002-01-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 23 | AP | 2002-09-03 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2002-11-13 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2002-11-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2002-12-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 28 | AP | 2003-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2003-05-21 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2003-07-09 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2003-10-10 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2004-06-08 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2004-06-24 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2006-08-25 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2007-04-13 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2007-12-04 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2009-11-06 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 2009-11-06 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2009-11-06 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2009-11-06 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2010-10-28 | UNKNOWN |
| REMS; REMS | SUPPL | 48 | AP | 2011-05-06 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 2013-01-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 50 | AP | 2013-02-06 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 51 | AP | 2013-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2013-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2015-05-21 | STANDARD |
| LABELING; Labeling | SUPPL | 55 | AP | 2019-05-02 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2020-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2022-03-16 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 42 | Null | 7 |
| SUPPL | 43 | Null | 7 |
| SUPPL | 44 | Null | 6 |
| SUPPL | 45 | Null | 6 |
| SUPPL | 46 | Null | 6 |
| SUPPL | 48 | Null | 7 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 15 |
| SUPPL | 51 | Null | 6 |
| SUPPL | 52 | Null | 6 |
| SUPPL | 53 | Null | 7 |
| SUPPL | 55 | Null | 7 |
| SUPPL | 56 | Null | 7 |
| SUPPL | 57 | Null | 15 |
TE Codes
CDER Filings
MERCK SHARP DOHME
cder:Array
(
[0] => Array
(
[ApplNo] => 20903
[companyName] => MERCK SHARP DOHME
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/020903s056,021546s012lbl.pdf#page=26"]
[products] => [{"drugName":"REBETOL","activeIngredients":"RIBAVIRIN","strength":"200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"REBETOL","activeIngredients":"RIBAVIRIN","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"01\/28\/2020","submission":"SUPPL-56","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020903s056,021546s012lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2020","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020903s056,021546s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2019","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020903s055,021546s011lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2015","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020903s051,021546s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2013","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020903s051,021546s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2013","submission":"SUPPL-50","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020903s050,021546s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2013","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020903s050,021546s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2010","submission":"SUPPL-46","supplementCategories":"REMS-Assessment","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020903s046,021546s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2010","submission":"SUPPL-46","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020903s046,021546s002lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2009","submission":"SUPPL-45","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021546s001,020903s042s043s044s045lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2009","submission":"SUPPL-45","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021546s001,020903s042s043s044s045lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2009","submission":"SUPPL-44","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021546s001,020903s042s043s044s045lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2009","submission":"SUPPL-44","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020903s039lbl.pdf\"}]","notes":""},{"actionDate":"08\/25\/2006","submission":"SUPPL-38","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020903s038lbl.pdf\"}]","notes":""},{"actionDate":"06\/24\/2004","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20903slr034_rebetol_lbl.pdf\"}]","notes":""},{"actionDate":"06\/08\/2004","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20903slr033_rebetron_lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2003","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20903slr032_rebetol_lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2003","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20903s30lbl_Rebetol.pdf\"}]","notes":""},{"actionDate":"06\/09\/2003","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20903slr028_rebetol_lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2003","submission":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20903slr029_rebetol_lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2002","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20903slr025_Rebetron_lbl.pdf\"}]","notes":""},{"actionDate":"09\/03\/2002","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20903s23lbl.pdf\"}]","notes":""},{"actionDate":"12\/28\/2001","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20903s13lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2001","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20903s10lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2001","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20903s14lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2001","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20903s8s11s12s16lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2001","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20903s8s11s12s16lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2001","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20903s8s11s12s16lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2001","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20903lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"REBETOL","submission":"RIBAVIRIN","actionType":"200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"REBETOL","submission":"RIBAVIRIN","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-01-28
)
)