Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETOPOSIDE | ETOPOSIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
07/17/1995 | 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 |
---|---|---|---|---|---|
01/08/2013 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
12/18/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/03/2001 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
09/19/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
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06/05/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/05/2001 | SUPPL-7 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
08/03/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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10/26/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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11/20/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/20/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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11/20/1996 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
ETOPOSIDE
INJECTABLE;INJECTION; 20MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ETOPOSIDE | ETOPOSIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074513 | ACCORD HLTHCARE |
ETOPOSIDE | ETOPOSIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074983 | FRESENIUS KABI USA |
ETOPOSIDE | ETOPOSIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074290 | HIKMA |
ETOPOSIDE | ETOPOSIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074529 | MEITHEAL |