Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017588
Company: CORDEN 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
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
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-Container/Carton Labels, Labeling-Package Insert 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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English