Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020873
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANGIOMAX | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/15/2000 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20873lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20873ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20873_Angiomax.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/02/2019 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020873s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020873Orig1s039ltr.pdf | |
| 12/21/2018 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020873s037lbl.pdf | |
| 03/21/2016 | SUPPL-36 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020873s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020873Orig1s036ltr.pdf | |
| 09/03/2015 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/2016 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2016 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/2015 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/2014 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/2013 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/2013 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020873s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020873Orig1s029ltr.pdf | |
| 02/15/2013 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/2012 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/2012 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2010 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020873s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020873s023ltr.pdf | |
| 09/02/2005 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020873s014ltr.pdf |
| 11/30/2005 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020873s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020873s011ltr.pdf | |
| 05/07/2004 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20873slr009ltr.pdf |
| 06/13/2005 | SUPPL-6 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020873s006ltr.pdf |
| 06/20/2002 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20873s004LTR.pdf |
| 06/22/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/14/2001 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/02/2001 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/02/2019 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020873s039lbl.pdf | |
| 12/21/2018 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020873s037lbl.pdf | |
| 03/21/2016 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020873s036lbl.pdf | |
| 03/21/2016 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020873s036lbl.pdf | |
| 05/17/2013 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020873s029lbl.pdf | |
| 06/23/2010 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020873s023lbl.pdf | |
| 11/30/2005 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020873s011lbl.pdf | |
| 12/15/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20873lbl.pdf |
ANGIOMAX
INJECTABLE;INTRAVENOUS; 250MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ANGIOMAX | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 020873 | SANDOZ |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206551 | ACCORD HLTHCARE |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 201577 | DR REDDYS |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205962 | EUGIA PHARMA |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090189 | FRESENIUS KABI USA |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090811 | HOSPIRA |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090816 | HOSPIRA |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091602 | MEITHEAL |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202471 | MYLAN INSTITUTIONAL |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 210031 | SHUANGCHENG |
| BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 213078 | SLATE RUN PHARMA |