Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021348
Company: ACTELION
Company: ACTELION
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZAVESCA | MIGLUSTAT | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/31/2003 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21348_zavesca_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21348ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-348_Zavesca.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/08/2020 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021348s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021348Orig1s016ltr.pdf | |
06/26/2019 | SUPPL-15 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021348Orig1s015ltr.pdf |
01/15/2016 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/30/2014 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/10/2014 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021348s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021348Orig1s010ltr.pdf | |
11/23/2010 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021348s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021348s008ltr.pdf | |
02/29/2008 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021348s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021348s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/08/2020 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021348s016lbl.pdf | |
02/10/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021348s010lbl.pdf | |
11/23/2010 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021348s008lbl.pdf | |
02/29/2008 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021348s005lbl.pdf | |
07/31/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21348_zavesca_lbl.pdf |
ZAVESCA
CAPSULE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MIGLUSTAT | MIGLUSTAT | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208342 | ANI PHARMS |
MIGLUSTAT | MIGLUSTAT | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209325 | BRECKENRIDGE |
YARGESA | MIGLUSTAT | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209821 | EDENBRIDGE PHARMS |
ZAVESCA | MIGLUSTAT | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 021348 | ACTELION |