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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216291
Company: DR REDDYS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription AP 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
07/06/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216291Orig1s000ltr.pdf

NEOSTIGMINE METHYLSULFATE

SOLUTION;INTRAVENOUS; 3MG/3ML (1MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216291 DR REDDYS
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 203629 FRESENIUS KABI USA
NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE 3MG/3ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216206 HIKMA
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