NDA 20903, held by Merck Sharp Dohme. Ribavirin.
As of Nov 13, 2026, NDA 20903 (Rebetol), held by Merck Sharp Dohme, was first approved by FDA on Jun 3, 1998, with 46 approved supplements and 0 published complete response letters.
| Mar 6, 2002 | Supplement 20Efficacy (new indication or use) | Approved | |
| Dec 28, 2001 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Dec 9, 1998 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Jun 3, 1998 | Original applicationNew dosage form · Priority review | Approved |
| Rebetol200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy** · capsule;oral | Ribavirin | Discontinued |
| Rebetol200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Ribavirin | DiscontinuedReference drug |
| Mar 16, 2022 | Supplement 57Labeling · Standard review | Approved | |
| Jan 28, 2020 | Supplement 56Labeling · Standard review | Approved | |
| May 2, 2019 | Supplement 55Labeling · Standard review | Approved | |
| May 21, 2015 | Supplement 53Labeling · Standard review | Approved | |
| Nov 15, 2013 | Supplement 52Labeling · Standard review | Approved | |
| May 31, 2013 | Supplement 51Labeling · Standard review | Approved | |
| Feb 6, 2013 | Supplement 50Labeling | Approved | |
| Jan 4, 2013 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| May 6, 2011 | Supplement 48REMS | Approved | |
| Oct 28, 2010 | Supplement 46Labeling | Approved | |
| Nov 6, 2009 | Supplement 42Labeling · Standard review | Approved | |
| Nov 6, 2009 | Supplement 43Labeling · Standard review | Approved | |
| Nov 6, 2009 | Supplement 44Labeling · Standard review | Approved | |
| Nov 6, 2009 | Supplement 45Labeling · Standard review | Approved | |
| Dec 4, 2007 | Supplement 40Labeling · Standard review | Approved | |
| Apr 13, 2007 | Supplement 39Labeling · Standard review | Approved | |
| Aug 25, 2006 | Supplement 38Labeling · Standard review | Approved | |
| Jun 24, 2004 | Supplement 34Labeling · Standard review | Approved | |
| Jun 8, 2004 | Supplement 33Labeling · Standard review | Approved | |
| Oct 10, 2003 | Supplement 32Labeling · Standard review | Approved | |
| Jul 9, 2003 | Supplement 30Labeling · Standard review | Approved | |
| Jun 9, 2003 | Supplement 28Labeling · Standard review | Approved | |
| May 21, 2003 | Supplement 29Labeling · Standard review | Approved | |
| Dec 20, 2002 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Nov 13, 2002 | Supplement 25Labeling · Standard review | Approved | |
| Nov 13, 2002 | Supplement 24Labeling · Standard review | Approved | None posted |
| Sep 3, 2002 | Supplement 23Labeling · Standard review | Approved | |
| Mar 6, 2002 | Supplement 20Efficacy (new indication or use) | Approved | |
| Feb 21, 2002 | Supplement 15Labeling · Standard review | Approved | |
| Jan 3, 2002 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Dec 28, 2001 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Nov 5, 2001 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Oct 31, 2001 | Supplement 10Labeling · Standard review | Approved | |
| Oct 24, 2001 | Supplement 14Labeling · Standard review | Approved | |
| Aug 29, 2001 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Jul 25, 2001 | Supplement 8Labeling · Standard review | Approved | |
| Jul 25, 2001 | Supplement 11Labeling · Standard review | Approved | |
| Jul 25, 2001 | Supplement 12Labeling · Standard review | Approved | |
| Jul 25, 2001 | Supplement 16Labeling · Standard review | Approved | |
| Mar 13, 2001 | Supplement 6Labeling · Standard review | Approved | |
| Mar 13, 2001 | Supplement 7Labeling · Standard review | Approved | |
| Feb 23, 2001 | Supplement 5Labeling · Standard review | Approved | |
| Dec 18, 2000 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 2, 2000 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Dec 9, 1998 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Dec 9, 1998 | Supplement 2Labeling · Standard review | Approved | |
| Jun 3, 1998 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
