Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017588
Company: LATINA PHARMA
Company: LATINA PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLEOSTINE | LOMUSTINE | 10MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| GLEOSTINE | LOMUSTINE | 40MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| GLEOSTINE | LOMUSTINE | 100MG | CAPSULE;ORAL | Prescription | None | Yes | Yes |
| GLEOSTINE | LOMUSTINE | 5MG | CAPSULE;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/04/2020 | SUPPL-46 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017588Orig1s046lbl.pdf | |
| 01/29/2016 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s043lbl.pdf | |
| 01/06/2016 | SUPPL-42 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s042lbl.pdf | |
| 01/06/2016 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s042lbl.pdf | |
| 05/20/2014 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017588s040lbl.pdf | |
| 08/15/2013 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017588s039lbl.pdf | |
| 11/21/2012 | SUPPL-36 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017588s036lbl.pdf | |
| 05/12/2011 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017588s037lbl.pdf | |
| 04/30/2009 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017588s034lbl.pdf |