Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211694
Company: NOVITIUM PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP;ORAL Prescription AA 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
03/08/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211694Orig1s000ltr.pdf

PYRIDOSTIGMINE BROMIDE

SYRUP;ORAL; 60MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MESTINON PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP;ORAL Prescription Yes AA 015193 BAUSCH
PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP;ORAL Prescription No AA 211694 NOVITIUM PHARMA

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