FDA Approval Activities for this Drug…

Mestinon (pyridostigmine) INJECTABLE ICN NDA 09829S9 7/26/01 4/3/02 Mestinon (pyridostigmine) Syrup, ICN NDA 15193/S-020 5/22/02 5/29/02 Mestinon (pyridostigmine bromide) Syrup Tablets and Timespan Tablets ICN NDA 15193/S-018 Pyridostigmine Bromide Tablets, 30 mg, U.S. Army Medical Research and Materiel Command NDA 20-414 2/5/03 2/5/03 2/13/03 4/25/03 Pyridostigmine Bromide Tablets, 60 mg, Barr ANDA 40-512 10/8/03 Pyridostigmine Bromide Tablets, 60 mg, Impax ANDA 40-507 4/24/03 Pyridostigmine Bromide Tablets, 60 mg, Corepharma ANDA 40-457 Regonol (Pyridostigmine Bromide) Injection, Sabex 2002, NDA 17-398/S14 | Regonol (pyridostigmine bromide) injection, Sabex 2002, Manufacturing Change or Addition

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