Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091596
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
03/02/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/24/2021 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
08/14/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
02/19/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
TRANEXAMIC ACID
INJECTABLE;INJECTION; 100MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYKLOKAPRON | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019281 | PFIZER |
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202436 | ACIC PHARMS |
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201885 | AM REGENT |
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208840 | AMNEAL PHARMS CO |
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209860 | APOTEX |
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203521 | AVET LIFESCIENCES |
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212360 | CAPLIN |
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202373 | EPIC PHARMA LLC |
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205035 | EUGIA PHARMA |
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091596 | FRESENIUS KABI USA |
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207239 | GLAND |
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206713 | MICRO LABS |
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091657 | MYLAN INSTITUTIONAL |
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212676 | PROVEPHARM SAS |
TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201580 | XGEN PHARMS |