Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 075493
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VINCRISTINE SULFATE PFS | VINCRISTINE SULFATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 09/01/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75493ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-493_Vincristine%20Sulfate.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/31/2015 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/13/2013 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/31/2015 | SUPPL-29 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/31/2015 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/23/2012 | SUPPL-22 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/17/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |
VINCRISTINE SULFATE PFS
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VINCRISTINE SULFATE PFS | VINCRISTINE SULFATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 071484 | HOSPIRA |
| VINCRISTINE SULFATE PFS | VINCRISTINE SULFATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075493 | TEVA PHARMS USA |
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