Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CERUBIDINE | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
02/03/1995 | 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 |
---|---|---|---|---|---|
12/13/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/20/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
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02/18/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
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11/19/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
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11/19/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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11/19/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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11/19/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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11/19/1999 | SUPPL-3 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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09/03/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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06/30/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CERUBIDINE
INJECTABLE;INJECTION; EQ 20MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CERUBIDINE | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 064103 | HIKMA |
DAUNORUBICIN HYDROCHLORIDE | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065000 | FRESENIUS KABI USA |