Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020906
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETOPOPHOS PRESERVATIVE FREE | ETOPOSIDE PHOSPHATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
ETOPOPHOS PRESERVATIVE FREE | ETOPOSIDE PHOSPHATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
02/27/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20906_Etopophos_appltr_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20906.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/05/2002 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20457slr006,20906slr002ltr.pdf |
08/16/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |