Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074983
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETOPOSIDE | ETOPOSIDE | 20MG/ML | 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 |
---|---|---|---|---|---|---|---|
09/30/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74983LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74983_Etoposide.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/05/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
10/11/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/01/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
06/23/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
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 |