Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020903
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REBETOL RIBAVIRIN 200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy** CAPSULE;ORAL Discontinued None No No
REBETOL RIBAVIRIN 200MG CAPSULE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/03/1998 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20903lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20903ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020903_rebetol_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/21/2015 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020903s053,021546s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020903Orig1s053,021546Orig1s009ltr.pdf
11/15/2013 SUPPL-52 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s052,021546s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s052,021546Orig1s008ltr.pdf
05/31/2013 SUPPL-51 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s051,021546s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s051,021546Orig1s007ltr.pdf
02/06/2013 SUPPL-50 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s050,021546s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s050,021546Orig1s006ltr.pdf
01/04/2013 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

05/06/2011 SUPPL-48 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020903s048,021546s004ltr.pdf
10/28/2010 SUPPL-46 Labeling, REMS-Assessment Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020903s046,021546s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020903s046,021546s002ltr.pdf
11/06/2009 SUPPL-45 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045,021546s001ltr.pdf
11/06/2009 SUPPL-44 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045,021546s001ltr.pdf
11/06/2009 SUPPL-43 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045,021546s001ltr.pdf
11/06/2009 SUPPL-42 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045,021546s001ltr.pdf
12/04/2007 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020903s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020903s040ltr.pdf
04/13/2007 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020903s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020903s039ltr.pdf
08/25/2006 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020903s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020903s038ltr.pdf
06/24/2004 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20903slr034_rebetol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20903slr034ltr.pdf
06/08/2004 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20903slr033_rebetron_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20903slr033ltr.pdf
10/10/2003 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr032_rebetol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020903_S32_REBETOL RETETRON.pdf
07/09/2003 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903s30lbl_Rebetol.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020903_S30_REBETOL REBETRON.pdf
05/21/2003 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr029_rebetol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr029ltr.pdf
06/09/2003 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr028_rebetol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr028ltr.pdf
12/20/2002 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/2002 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20903slr025_Rebetron_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903slr025ltr.pdf
11/13/2002 SUPPL-24 Labeling

Label is not available on this site.

09/03/2002 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20903s23lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903slr023ltr.pdf
01/03/2002 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/2002 SUPPL-20 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903s20ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-903s020_Rebetol.cfm
08/29/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/2001 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903s008s011s012s016_Rebetol.cfm
02/21/2002 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903s15ltr.pdf
10/24/2001 SUPPL-14 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s14lbl.pdf
12/28/2001 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s13ltr.pdf
07/25/2001 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903s008s011s012s016_Rebetol.cfm
07/25/2001 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903s008s011s012s016_Rebetol.cfm
10/31/2001 SUPPL-10 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s10lbl.pdf
07/25/2001 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903s008s011s012s016_Rebetol.cfm
03/13/2001 SUPPL-7 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s7ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903S006S007_Rebetol.pdf
03/13/2001 SUPPL-6 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s7ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903S006S007_Rebetol.pdf
02/23/2001 SUPPL-5 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s5lbl.pdf
12/18/2000 SUPPL-4 Labeling

Label is not available on this site.

03/02/2000 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/09/1998 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20903s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20903s1ltr.pdf
12/09/1998 SUPPL-1 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20903s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20903s1ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/21/2015 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020903s053,021546s009lbl.pdf
11/15/2013 SUPPL-52 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s052,021546s008lbl.pdf
11/15/2013 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s052,021546s008lbl.pdf
05/31/2013 SUPPL-51 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s051,021546s007lbl.pdf
05/31/2013 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s051,021546s007lbl.pdf
02/06/2013 SUPPL-50 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s050,021546s006lbl.pdf
02/06/2013 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s050,021546s006lbl.pdf
10/28/2010 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020903s046,021546s002lbl.pdf
10/28/2010 SUPPL-46 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020903s046,021546s002lbl.pdf
11/06/2009 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf
11/06/2009 SUPPL-45 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf
11/06/2009 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf
11/06/2009 SUPPL-44 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf
11/06/2009 SUPPL-43 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf
11/06/2009 SUPPL-43 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf
11/06/2009 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf
11/06/2009 SUPPL-42 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf
12/04/2007 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020903s040lbl.pdf
04/13/2007 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020903s039lbl.pdf
08/25/2006 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020903s038lbl.pdf
06/24/2004 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20903slr034_rebetol_lbl.pdf
06/08/2004 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20903slr033_rebetron_lbl.pdf
10/10/2003 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr032_rebetol_lbl.pdf
07/09/2003 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903s30lbl_Rebetol.pdf
06/09/2003 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr028_rebetol_lbl.pdf
05/21/2003 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr029_rebetol_lbl.pdf
11/13/2002 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20903slr025_Rebetron_lbl.pdf
09/03/2002 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20903s23lbl.pdf
12/28/2001 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s13lbl.pdf
10/31/2001 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s10lbl.pdf
10/24/2001 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s14lbl.pdf
07/25/2001 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf
07/25/2001 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf
07/25/2001 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf
07/25/2001 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf
02/23/2001 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s5lbl.pdf
12/09/1998 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20903s1lbl.pdf
12/09/1998 SUPPL-1 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20903s1lbl.pdf
06/03/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20903lbl.pdf

REBETOL

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REBETOL RIBAVIRIN 200MG CAPSULE;ORAL Prescription Yes AB 020903 MERCK SHARP DOHME
RIBASPHERE RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 076203 KADMON PHARMS LLC
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 079117 AUROBINDO PHARMA
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 076192 CASI PHARMS INC
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 076277 TEVA
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 077224 ZYDUS PHARMS USA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English