Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062812
Company: STERISCIENCE
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| VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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| VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
| VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 11/17/1987 | 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 |
|---|---|---|---|---|---|
| 05/24/2021 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/18/2020 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/12/2017 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/12/2017 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/12/2017 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/24/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 06/20/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/04/1994 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 01/12/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 11/08/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 11/03/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |