Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075811
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MESNA | MESNA | 100MG/ML | INJECTABLE;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/2001 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-811_Mesna_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75811ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-811_Mesna.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/15/2019 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/13/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/26/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-811_Mesna_prntlbl.pdf |
MESNA
INJECTABLE;INTRAVENOUS; 100MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MESNA | MESNA | 100MG/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 075811 | FRESENIUS KABI USA |
| MESNA | MESNA | 100MG/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206992 | GLAND |
| MESNA | MESNA | 100MG/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 075739 | HIKMA |
| MESNA | MESNA | 100MG/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090913 | SAGENT PHARMS INC |
| MESNEX | MESNA | 100MG/ML | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 019884 | BAXTER HLTHCARE |