Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021107
Company: SEBELA IRELAND LTD
Company: SEBELA IRELAND LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOTRONEX | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
| LOTRONEX | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 02/09/2000 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21107ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21107a_Lotronex.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/08/2023 | SUPPL-30 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021107Orig1s030ltr.pdf |
| 04/03/2019 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021107s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021107Orig1s029ltr.pdf | |
| 01/07/2016 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021107s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021107Orig1s027ltr.pdf | |
| 01/07/2016 | SUPPL-26 | REMS-Modified |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021107Orig1s026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021107Orig1s026.pdf |
| 07/24/2015 | SUPPL-25 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021107Orig1s025ltr.pdf |
| 05/08/2014 | SUPPL-24 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021107Orig1s024ltr.pdf |
| 04/19/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/2010 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021107s016ltr.pdf | |
| 09/02/2010 | SUPPL-14 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021107s014ltr.pdf | |
| 04/01/2008 | SUPPL-13 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021107s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021107s013ltr.pdf | |
| 03/10/2006 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021107s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021107s012ltr.pdf | |
| 02/18/2005 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21107s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21107s011ltr.pdf | |
| 02/04/2005 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021107s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21107s010ltr.pdf | |
| 01/31/2005 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 12/23/2003 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21107scf008_lotronex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21107scf008ltr.pdf | |
| 03/20/2003 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21107slr007ltr.pdf |
| 06/03/2002 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021107_S006_LOTRONEX_TABLETS.pdf |
| 06/07/2002 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21107s5lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21107s5ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021107_S005_LOTRONEX_TABLETS.pdf | |
| 08/11/2000 | SUPPL-2 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021107_S002_LOTRONEX_TABLET.pdf |
| 03/07/2000 | SUPPL-1 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021107_S001_LOTRONEX_TABLET.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/03/2019 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021107s029lbl.pdf | |
| 01/07/2016 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021107s027lbl.pdf | |
| 09/02/2010 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s016lbl.pdf | |
| 09/02/2010 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s016lbl.pdf | |
| 09/02/2010 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s014lbl.pdf | |
| 09/02/2010 | SUPPL-14 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021107s014lbl.pdf | |
| 04/01/2008 | SUPPL-13 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021107s013lbl.pdf | |
| 03/10/2006 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021107s012lbl.pdf | |
| 02/18/2005 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21107s011lbl.pdf | |
| 02/04/2005 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021107s010lbl.pdf | |
| 12/23/2003 | SUPPL-8 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21107scf008_lotronex_lbl.pdf | |
| 06/07/2002 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21107s5lbl.pdf | |
| 02/09/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21107lbl.pdf |
LOTRONEX
TABLET;ORAL; EQ 1MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 206647 | AMNEAL PHARMS |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 213614 | MANKIND PHARMA |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 209180 | RISING |
| LOTRONEX | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021107 | SEBELA IRELAND LTD |
TABLET;ORAL; EQ 0.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 206647 | AMNEAL PHARMS |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 213614 | MANKIND PHARMA |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 209180 | RISING |
| LOTRONEX | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021107 | SEBELA IRELAND LTD |