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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013684
Company: BAXTER HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OSMITROL 10% IN WATER MANNITOL 10GM/100ML INJECTABLE;INJECTION Prescription AP No No
OSMITROL 10% IN WATER IN PLASTIC CONTAINER MANNITOL 10GM/100ML INJECTABLE;INJECTION Prescription AP No No
OSMITROL 15% IN WATER MANNITOL 15GM/100ML INJECTABLE;INJECTION Prescription AP No No
OSMITROL 15% IN WATER IN PLASTIC CONTAINER MANNITOL 15GM/100ML INJECTABLE;INJECTION Prescription AP No No
OSMITROL 20% IN WATER MANNITOL 20GM/100ML INJECTABLE;INJECTION Prescription AP No No
OSMITROL 20% IN WATER IN PLASTIC CONTAINER MANNITOL 20GM/100ML INJECTABLE;INJECTION Prescription AP No No
OSMITROL 5% IN WATER MANNITOL 5GM/100ML INJECTABLE;INJECTION Prescription AP No No
OSMITROL 5% IN WATER IN PLASTIC CONTAINER MANNITOL 5GM/100ML INJECTABLE;INJECTION Prescription AP No No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/05/2019 SUPPL-106 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/013684s106lbl.pdf
11/15/2018 SUPPL-104 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/013684s104lbl.pdf
11/15/2018 SUPPL-98 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/013684s098lbl.pdf
08/26/2005 SUPPL-92 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf
06/09/2005 SUPPL-91 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s091lbl.pdf
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