Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074290
Company: HIKMA
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. |
||
| 06/05/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 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. |
||
| 10/26/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 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. |
||
| 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 |