Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020903
Company: MERCK SHARP DOHME
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| REBETOL | RIBAVIRIN | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
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 |
|---|---|---|---|---|---|
| 03/16/2022 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020903s057,021546s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020903Orig1s057, 021546Orig1s013ltr.pdf | |
| 01/28/2020 | SUPPL-56 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020903s056,021546s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020903Orig1s056,021546Orig1s012ltr.pdf | |
| 05/02/2019 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020903s055,021546s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020903Orig1s055, 021546Orig1s011ltr.pdf | |
| 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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s13ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/020903Orig1s013.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 |
|---|---|---|---|---|---|
| 03/16/2022 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020903s057,021546s013lbl.pdf | |
| 01/28/2020 | SUPPL-56 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020903s056,021546s012lbl.pdf | |
| 01/28/2020 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020903s056,021546s012lbl.pdf | |
| 05/02/2019 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020903s055,021546s011lbl.pdf | |
| 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 |