Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062943
Company: ALMAJECT
Company: ALMAJECT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | 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 |
|---|---|---|---|---|---|---|---|
| 09/29/1988 | 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 |
|---|---|---|---|---|---|
| 05/28/2026 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/28/2026 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/28/2026 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/28/2026 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/28/2026 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/18/2013 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/10/2008 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 08/12/2005 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 04/12/2004 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 01/23/2001 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/26/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 08/03/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/09/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 10/22/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 10/22/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 10/18/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |