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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021546
Company: SCHERING

Medication Guide

Products on NDA 021546

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REBETOL	RIBAVIRIN	40MG/ML	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021546

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2003	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21546_rebetol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21546ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-546_Rebetol.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/16/2022	SUPPL-13	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-12	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-11	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-9	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-8	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-7	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-6	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
09/25/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/06/2011	SUPPL-4	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-2	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-1	Labeling-Medication Guide	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

Labels for NDA 021546

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/16/2022	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020903s057,021546s013lbl.pdf
01/28/2020	SUPPL-12	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020903s056,021546s012lbl.pdf
01/28/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020903s056,021546s012lbl.pdf
05/02/2019	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020903s055,021546s011lbl.pdf
05/21/2015	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020903s053,021546s009lbl.pdf
11/15/2013	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s052,021546s008lbl.pdf
05/31/2013	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s051,021546s007lbl.pdf
05/31/2013	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s051,021546s007lbl.pdf
02/06/2013	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s050,021546s006lbl.pdf
10/28/2010	SUPPL-2	REMS-Assessment	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020903s046,021546s002lbl.pdf
11/06/2009	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf
07/29/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21546_rebetol_lbl.pdf

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