Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062800
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 |
|---|---|---|---|---|---|---|---|
| 07/24/1987 | 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 |
|---|---|---|---|---|---|
| 05/28/2026 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/28/2026 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/28/2026 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/28/2026 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/28/2026 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/28/2026 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/18/2013 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/10/2008 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 08/12/2005 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 07/12/2004 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 01/23/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/26/2000 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 08/03/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/17/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 06/20/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 02/24/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/28/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 10/22/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |