Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062682
Company: HIKMA
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| VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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| VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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| VANCOMYCIN HYDROCHLORIDE | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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| VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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| VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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. |