Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022430
Company: AMRING PHARMS
Company: AMRING PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LYSTEDA | TRANEXAMIC ACID | 650MG | TABLET;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 |
---|---|---|---|---|---|---|---|
11/13/2009 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022430lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022430s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022430_lysteda_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022430s000sumr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/07/2020 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022430s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022430Orig1s009ltr.pdf | |
05/23/2016 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/23/2015 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/03/2013 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022430Orig1s004ltr.pdf | |
08/21/2013 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022430Orig1s003ltr.pdf | |
04/06/2011 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022430s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022430s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/022430Orig1s002.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/07/2020 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022430s009lbl.pdf | |
10/03/2013 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s004lbl.pdf | |
08/21/2013 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s003lbl.pdf | |
04/06/2011 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022430s002lbl.pdf | |
11/13/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022430lbl.pdf |
LYSTEDA
TABLET;ORAL; 650MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LYSTEDA | TRANEXAMIC ACID | 650MG | TABLET;ORAL | Prescription | Yes | AB | 022430 | AMRING PHARMS |
TRANEXAMIC ACID | TRANEXAMIC ACID | 650MG | TABLET;ORAL | Prescription | No | AB | 202093 | ACTAVIS LABS FL INC |
TRANEXAMIC ACID | TRANEXAMIC ACID | 650MG | TABLET;ORAL | Prescription | No | AB | 203256 | ANI PHARMS |
TRANEXAMIC ACID | TRANEXAMIC ACID | 650MG | TABLET;ORAL | Prescription | No | AB | 205133 | AUROBINDO PHARMA USA |
TRANEXAMIC ACID | TRANEXAMIC ACID | 650MG | TABLET;ORAL | Prescription | No | AB | 218320 | RUBICON |