Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089395
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VINBLASTINE SULFATE | VINBLASTINE SULFATE | 10MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/09/1987 | 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 |
|---|---|---|---|---|---|
| 08/22/2002 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/21/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/05/1997 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/25/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 04/02/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 04/24/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 04/13/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/13/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |