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 | Yes |
| GLEOSTINE | LOMUSTINE | 100MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| GLEOSTINE | LOMUSTINE | 5MG | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/04/1976 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017588Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017588Orig1s046ltr.pdf | |
| 01/29/2016 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017588Orig1s043ltr.pdf | |
| 01/06/2016 | SUPPL-42 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017588Orig1s042ltr.pdf | |
| 01/05/2015 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/2014 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017588s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017588Orig1s040ltr.pdf | |
| 08/15/2013 | SUPPL-39 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017588s039lbl.pdf | |
| 08/14/2013 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/2011 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017588s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017588s037ltr.pdf | |
| 11/21/2012 | SUPPL-36 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017588s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017588Orig1s036ltr.pdf | |
| 04/30/2009 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017588s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017588s034ltr.pdf | |
| 02/27/2003 | SUPPL-33 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17588slr033ltr.pdf |
| 06/01/1999 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/2002 | SUPPL-31 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17588slr031ltr.pdf |
| 03/02/1993 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/01/1990 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/14/1988 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1991 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/1988 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1987 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/1986 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/1986 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1986 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/22/1986 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 06/18/1985 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1985 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1983 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/22/1983 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/14/1986 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/16/1982 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/12/1980 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/12/1980 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/07/1980 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/19/1980 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/14/1978 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/22/1977 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s042lbl.pdf | |
| 01/06/2016 | SUPPL-42 | Labeling-Container/Carton Labels | 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 |