Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205035
Company: EUGIA PHARMA
Company: EUGIA PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 01/14/2016 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205035Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/06/2021 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/10/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/14/2018 | SUPPL-1 | Labeling |
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 |