Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103471
Company: BAYER HEALTHCARE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BETASERON INTERFERON BETA-1B 0.3 MG VIAL; SUBCUTANEOUS Prescription None No 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
07/23/1993 ORIG-1 Approval N/A; Orphan Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/103471s0000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/20/2020 SUPPL-5199 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103471Orig1s5199ltr.pdf
10/01/2020 SUPPL-5197 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103471s5197lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103471Orig1s5197ltr.pdf
08/16/2019 SUPPL-5195 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103471s5195lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103471Orig1s5195ltr.pdf
08/31/2018 SUPPL-5193 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103471s5193lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103471Orig1s5193ltr.pdf
06/08/2018 SUPPL-5191 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103471Orig1s5191ltr.pdf
05/26/2017 SUPPL-5189 Supplement Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103471Orig1s5189ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/103471Orig1s5189.pdf
12/22/2015 SUPPL-5188 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103471s5188lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103471Orig1s5188ltr.pdf
04/19/2016 SUPPL-5187 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103471s5157lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103471Orig1s5187ltr.pdf
09/25/2015 SUPPL-5186 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103471s5186lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103471Orig1s5186ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/103471Orig1s5186.pdf
01/28/2014 SUPPL-5185 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103471s5185lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103471Orig1s5185ltr.pdf
04/19/2016 SUPPL-5157 Supplement

Label is not available on this site.

12/11/2012 SUPPL-5138 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf
12/11/2012 SUPPL-5136 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf
03/26/2009 SUPPL-5132 Supplement

Label is not available on this site.

06/28/2013 SUPPL-5125 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103471s5125lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103471Orig1s5125ltr.pdf
12/11/2012 SUPPL-5124 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf
09/08/2008 SUPPL-5121 Supplement

Label is not available on this site.

12/11/2012 SUPPL-5120 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf
07/18/2007 SUPPL-5097 Supplement

Label is not available on this site.

12/11/2012 SUPPL-5088 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf
11/09/2006 SUPPL-5085 Supplement

Label is not available on this site.

04/26/2007 SUPPL-5084 Supplement

Label is not available on this site.

04/04/2006 SUPPL-5082 Supplement

Label is not available on this site.

10/20/2006 SUPPL-5081 Supplement

Label is not available on this site.

12/11/2012 SUPPL-5079 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf
12/29/2005 SUPPL-5075 Supplement

Label is not available on this site.

12/29/2005 SUPPL-5071 Supplement

Label is not available on this site.

12/07/2005 SUPPL-5069 Supplement

Label is not available on this site.

12/11/2012 SUPPL-5067 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf
07/28/2005 SUPPL-5066 Supplement

Label is not available on this site.

07/28/2005 SUPPL-5065 Supplement

Label is not available on this site.

12/11/2012 SUPPL-5063 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103471Origs5063,s5067,s5079,s5088,s5120,s5124,s5136,s5138ltr.pdf
06/08/2005 SUPPL-5060 Supplement

Label is not available on this site.

10/10/2003 SUPPL-5032 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/103471s5032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103471-5032ltr.pdf
03/14/2003 SUPPL-1039 Supplement Label (PDF)
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbchi031403LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbchi031403L.htm https://web.archive.org/web/20170118085127/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080486.htm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/01/2020 SUPPL-5197 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103471s5197lbl.pdf
08/16/2019 SUPPL-5195 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103471s5195lbl.pdf
08/31/2018 SUPPL-5193 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103471s5193lbl.pdf
04/19/2016 SUPPL-5187 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103471s5157lbl.pdf
04/19/2016 SUPPL-5187 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103471s5157lbl.pdf
12/22/2015 SUPPL-5188 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103471s5188lbl.pdf
09/25/2015 SUPPL-5186 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103471s5186lbl.pdf
01/28/2014 SUPPL-5185 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103471s5185lbl.pdf
06/28/2013 SUPPL-5125 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103471s5125lbl.pdf
12/11/2012 SUPPL-5138 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf
12/11/2012 SUPPL-5136 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf
12/11/2012 SUPPL-5124 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf
12/11/2012 SUPPL-5120 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf
12/11/2012 SUPPL-5088 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf
12/11/2012 SUPPL-5079 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf
12/11/2012 SUPPL-5067 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf
12/11/2012 SUPPL-5063 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103471s5063s5067s5079s5088s5120s5124s5136s5138lbl.pdf
10/10/2003 SUPPL-5032 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/103471s5032lbl.pdf
03/14/2003 SUPPL-1039 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbchi031403LB.pdf

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