Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203629
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription None No No
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription None No No
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription None 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
01/08/2015 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203629s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203629Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203629Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203629Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/31/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/08/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203629s000lbl.pdf

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