Drugs@FDA: FDA-Approved Drugs
Company: STERISCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
11/06/1964 | 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 |
---|---|---|---|---|---|
10/18/2022 | SUPPL-50 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
01/29/2021 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/060180s049lbl.pdf | |
12/18/2017 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060180s048lbl.pdf | |
01/31/2017 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060180s047lbl.pdf | |
01/31/2017 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
07/20/1998 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/24/1996 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
04/24/1996 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
07/01/1996 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/12/1995 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/12/1995 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/04/1994 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
05/24/1995 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
01/11/1993 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
04/10/1990 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/15/1991 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/29/2021 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/060180s049lbl.pdf | |
12/18/2017 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060180s048lbl.pdf | |
01/31/2017 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060180s047lbl.pdf |