Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062879
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/02/1988 | 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 |
|---|---|---|---|---|---|
| 06/11/2021 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/11/2021 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/15/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/15/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/30/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 08/19/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/28/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/27/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 11/09/1990 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/26/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/27/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/26/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |