Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019884
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MESNEX | MESNA | 100MG/ML | INJECTABLE;INTRAVENOUS | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/30/1988 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/17/2018 | SUPPL-16 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019884s016,020855s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019884Orig1s016, 020855Orig1s003ltr.pdf | |
02/26/2016 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/17/2014 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019884s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019884Orig1s013,020855Orig1s002ltr.pdf | |
01/30/2003 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19884slr007,008ltr.pdf |
01/30/2003 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19884slr007,008ltr.pdf |
07/26/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/25/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
05/23/1996 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/22/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/16/1994 | SUPPL-2 | 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 |
---|---|---|---|---|---|
12/17/2018 | SUPPL-16 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019884s016,020855s003lbl.pdf | |
12/17/2018 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019884s016,020855s003lbl.pdf | |
03/17/2014 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019884s013lbl.pdf |
MESNEX
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 |