Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019618
Company: MYLAN SPECIALITY LP
Company: MYLAN SPECIALITY LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROWASA | MESALAMINE | 4GM/60ML | ENEMA;RECTAL | Prescription | AB | Yes | Yes |
| SFROWASA | MESALAMINE | 4GM/60ML | ENEMA;RECTAL | Prescription | AB | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/01/2021 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019618s029lbl.pdf | |
| 06/25/2021 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019618s027lbl.pdf | |
| 10/01/2020 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019618s026lbl.pdf | |
| 07/27/2017 | SUPPL-23 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019618s023lbl.pdf | |
| 07/27/2017 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019618s023lbl.pdf | |
| 06/20/2008 | SUPPL-18 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019618s018lbl.pdf | |
| 06/20/2008 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019618s018lbl.pdf |