Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202093
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRANEXAMIC ACID | TRANEXAMIC ACID | 650MG | TABLET;ORAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
12/27/2012 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
Letter (PDF) Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202093s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202093Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202093Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/22/2021 | SUPPL-9 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
08/20/2015 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
TRANEXAMIC ACID
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 |