Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205650
Company: ZYDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG TABLET;ORAL Prescription AB 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
06/22/2015 ORIG-1 Approval STANDARD

Label is not available on this site.

PYRIDOSTIGMINE BROMIDE

TABLET;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MESTINON PYRIDOSTIGMINE BROMIDE 60MG TABLET;ORAL Prescription Yes AB 009829 BAUSCH
PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG TABLET;ORAL Prescription No AB 211181 APNAR PHARMA LP
PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG TABLET;ORAL Prescription No AB 040502 IMPAX LABS
PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 60MG TABLET;ORAL Prescription No AB 205650 ZYDUS PHARMS

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