Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022453
Company: MEITHEAL
Company: MEITHEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
12/20/2012 | 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/2012/022453s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022453Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022453_topotecan_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022453Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/24/2019 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022453s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022453Orig1s011ltr.pdf | |
09/20/2017 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022453s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022453Orig1s010ltr.pdf | |
11/14/2016 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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12/21/2015 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/29/2016 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022453s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022453Orig1s007ltr.pdf | |
03/30/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/23/2015 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/23/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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02/28/2014 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022453s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022453Orig1s002ltr.pdf | |
10/03/2013 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/24/2019 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022453s011lbl.pdf | |
09/20/2017 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022453s010lbl.pdf | |
01/29/2016 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022453s007lbl.pdf | |
02/28/2014 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022453s002lbl.pdf | |
12/20/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022453s000lbl.pdf |
TOPOTECAN HYDROCHLORIDE
SOLUTION;INTRAVENOUS; EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 204406 | ACCORD HLTHCARE |
TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 200582 | HOSPIRA INC |
TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 022453 | MEITHEAL |