Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VINCRISTINE SULFATE PFS | VINCRISTINE SULFATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | None | No | 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 |
---|---|---|---|---|---|---|---|
04/19/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/14/2021 | SUPPL-47 | Labeling-Package Insert |
Label is not available on this site. |
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09/22/2021 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
09/23/2019 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
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08/05/2014 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071484s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/071484Orig1s042ltr.pdf | |
05/07/2013 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
04/24/2015 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
01/23/2012 | SUPPL-38 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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01/25/2007 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
09/25/2001 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
05/14/2001 | SUPPL-24 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
08/08/2000 | SUPPL-22 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
05/18/2000 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
05/12/2000 | SUPPL-20 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
04/07/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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07/02/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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11/07/1995 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
04/28/1995 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
04/16/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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07/01/1994 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
11/03/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
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07/16/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/04/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
04/06/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/06/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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07/14/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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06/20/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/05/2014 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071484s042lbl.pdf |