Drugs@FDA: FDA-Approved Drugs
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZANOSAR | STREPTOZOCIN | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 05/07/1982 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/14/2016 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/2015 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/2015 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/2014 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/2014 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/2012 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/2013 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/2012 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/2012 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/2012 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/2003 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50577slr016ltr.pdf |
| 04/03/2000 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/30/2002 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50577slr014ltr.pdf |
| 05/05/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/29/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/27/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1993 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/11/1994 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/22/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/17/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |