Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VANCOLED | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
VANCOLED | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
VANCOLED | VANCOMYCIN HYDROCHLORIDE | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
VANCOLED | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
VANCOLED | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
07/22/1986 | 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-19 | Labeling-Package Insert |
Label is not available on this site. |
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06/11/2021 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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10/23/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/31/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/29/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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12/05/1995 | SUPPL-13 | Labeling |
Label is not available on this site. |
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03/10/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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04/22/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
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03/05/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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09/09/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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03/01/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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03/30/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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05/11/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |