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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019618
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
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