Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103132
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INTRON A | INTERFERON ALFA-2B | 10MIU/VIAL | VIAL | Prescription | None | No | No |
| INTRON A | INTERFERON ALFA-2B | 18MIU/VIAL | VIAL | Prescription | None | No | No |
| INTRON A | INTERFERON ALFA-2B | 25MIU/VIAL | VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 06/04/1986 | ORIG-1 | Approval | N/A |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/103132Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/26/2021 | SUPPL-5202 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103132s5202lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103132Orig1s5202ltr.pdf | |
| 05/04/2018 | SUPPL-5199 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103132Orig1s5199lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103132Orig1s5199ltr.pdf | |
| 10/02/2017 | SUPPL-5196 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5196lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103132Orig1s5196ltr.pdf | |
| 06/12/2017 | SUPPL-5195 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5195lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103132Orig1s5195ltr.pdf | |
| 05/21/2015 | SUPPL-5191 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103132s5191lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103132Orig1s5191ltr.pdf | |
| 08/11/2014 | SUPPL-5190 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103132s5190lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103132Origs5190ltr.pdf | |
| 04/02/2014 | SUPPL-5183 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103132s5183lbl.pdf | |
| 11/15/2013 | SUPPL-5178 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103132s5178lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103132Orig1s5178ltr.pdf | |
| 06/04/2012 | SUPPL-5163 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103132s5163ltr.pdf |
| 12/20/2011 | SUPPL-5161 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103132s5161lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103132s5161ltr.pdf | |
| 05/13/2011 | SUPPL-5153 | Supplement |
Label is not available on this site. |
||
| 06/06/2011 | SUPPL-5148 | Supplement |
Label is not available on this site. |
||
| 02/01/2011 | SUPPL-5143 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103132s5143ltr.pdf |
| 07/21/2010 | SUPPL-5140 | Supplement |
Label is not available on this site. |
||
| 08/07/2009 | SUPPL-5122 | Supplement |
Label is not available on this site. |
||
| 02/16/2010 | SUPPL-5118 | Supplement |
Label is not available on this site. |
||
| 05/02/2008 | SUPPL-5108 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103132s5108ltr.pdf |
| 07/13/2007 | SUPPL-5096 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103132s5096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103132s5096ltr.pdf | |
| 05/22/2007 | SUPPL-5095 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103132s5095lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103132s5095ltr.pdf | |
| 07/28/2006 | SUPPL-5086 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103132s5086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103132s5086ltr.pdf | |
| 10/27/2004 | SUPPL-5064 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103132_5064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103132_5064ltr.pdf | |
| 05/22/2007 | SUPPL-5059 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103132s5095ltr.pdf |
| 06/21/2002 | SUPPL-5022 | Supplement |
Label is not available on this site. |
||
| 11/26/2003 | SUPPL-5018 | Supplement |
Label is not available on this site. |
||
| 11/29/2001 | SUPPL-5016 | Supplement |
Label is not available on this site. |
||
| 11/29/2001 | SUPPL-5009 | Supplement |
Label is not available on this site. |
||
| 02/01/2002 | SUPPL-5006 | Supplement |
Label is not available on this site. |
||
| 06/21/2001 | SUPPL-1144 | Supplement |
Label is not available on this site. |
||
| 08/18/1998 | SUPPL-1127 | Supplement |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-1120 | Supplement |
Label is not available on this site. |
||
| 11/06/1997 | SUPPL-1116 | Supplement |
Label (PDF)
Letter Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/ifnasch110697-lab.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/ifnasch110697L.htm https://www.accessdata.fda.gov/drugsatfda_docs/bla/1997/ifnasch110697r.pdf | |
| 03/26/1997 | SUPPL-1107 | Supplement |
Label is not available on this site. |
||
| 12/05/1995 | SUPPL-1096 | Supplement |
Label is not available on this site. |
||
| 05/14/1993 | SUPPL-1040 | Supplement |
Label is not available on this site. |
||
| 07/13/1992 | SUPPL-1030 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/26/2021 | SUPPL-5202 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103132s5202lbl.pdf | |
| 05/04/2018 | SUPPL-5199 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103132Orig1s5199lbl.pdf | |
| 10/02/2017 | SUPPL-5196 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5196lbl.pdf | |
| 10/02/2017 | SUPPL-5196 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5196lbl.pdf | |
| 06/12/2017 | SUPPL-5195 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5195lbl.pdf | |
| 05/21/2015 | SUPPL-5191 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103132s5191lbl.pdf | |
| 05/21/2015 | SUPPL-5191 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103132s5191lbl.pdf | |
| 08/11/2014 | SUPPL-5190 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103132s5190lbl.pdf | |
| 04/02/2014 | SUPPL-5183 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103132s5183lbl.pdf | |
| 11/15/2013 | SUPPL-5178 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103132s5178lbl.pdf | |
| 12/20/2011 | SUPPL-5161 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103132s5161lbl.pdf | |
| 07/13/2007 | SUPPL-5096 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103132s5096lbl.pdf | |
| 05/22/2007 | SUPPL-5095 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103132s5095lbl.pdf | |
| 07/28/2006 | SUPPL-5086 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103132s5086lbl.pdf | |
| 10/27/2004 | SUPPL-5064 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103132_5064lbl.pdf | |
| 11/06/1997 | SUPPL-1116 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/ifnasch110697-lab.pdf |