Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103471
Company: BAYER HEALTHCARE PHARMS
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 |
|---|---|---|---|---|---|
| 05/09/2024 | SUPPL-5203 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103471Orig1s5203ltr.pdf |
| 07/28/2023 | SUPPL-5202 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103471s5202lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103471Orig1s5202ltr.pdf | |
| 09/02/2022 | SUPPL-5201 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103471s5201lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/103471Orig1s5201ltr.pdf | |
| 11/03/2021 | SUPPL-5200 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103471s5200lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103471Orig1s5200ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 07/28/2023 | SUPPL-5202 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103471s5202lbl.pdf | |
| 09/02/2022 | SUPPL-5201 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103471s5201lbl.pdf | |
| 09/02/2022 | SUPPL-5201 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103471s5201lbl.pdf | |
| 11/03/2021 | SUPPL-5200 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103471s5200lbl.pdf | |
| 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 |