Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205133
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
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 |
---|---|---|---|---|---|---|---|
09/21/2015 | ORIG-1 | Approval | STANDARD |
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 |