Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 200199
Company: SANDOZ INC
Company: SANDOZ INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOPOTECAN | TOPOTECAN HYDROCHLORIDE | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
TOPOTECAN | TOPOTECAN HYDROCHLORIDE | EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
TOPOTECAN | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
02/25/2011 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200199s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200199s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200199_topotecan_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200199Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/28/2014 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200199s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200199Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/28/2014 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200199s003lbl.pdf | |
02/25/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200199s000lbl.pdf |