Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212702
Company: AMNEAL PHARMS LLC
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
01/10/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212702Orig1s000ltr.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 212702 AMNEAL PHARMS LLC
PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP;ORAL Prescription No AA 208797 INVATECH
PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP;ORAL Prescription No AA 211694 NOVITIUM PHARMA

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