Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021231
Company: ASTRAZENECA
Company: ASTRAZENECA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZOMIG-ZMT | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
ZOMIG-ZMT | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING;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 |
---|---|---|---|---|---|---|---|
02/13/2001 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21231lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21231ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-231_Zomig.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/21/2018 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020768s023,021231s014,021450s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020768Orig1s023,021231Orig1s014,021450Orig1s010Ltr.pdf | |
09/14/2012 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf | |
09/14/2012 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf | |
08/11/2010 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021231s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021231s009ltr.pdf | |
01/08/2004 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21231slr005,20768slr013ltr.pdf |
05/21/2003 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20768slr011,21231slr004ltr.pdf |
10/09/2002 | SUPPL-3 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20768slr010,21231slr003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021231_S003_ZOMIG_TABLETS.pdf |
12/04/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/17/2001 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/21/2018 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020768s023,021231s014,021450s010lbl.pdf | |
09/14/2012 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf | |
09/14/2012 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf | |
08/11/2010 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021231s009lbl.pdf | |
02/13/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21231lbl.pdf |