Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009829
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MESTINON PYRIDOSTIGMINE BROMIDE 60MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/06/1955 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/16/2014 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/09/2014 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/20/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/30/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/10/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/2001 SUPPL-11 Labeling

Label is not available on this site.

10/24/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/26/2001 SUPPL-9 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf
01/27/1986 SUPPL-7 Labeling

Label is not available on this site.

02/18/1981 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/26/2001 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf

MESTINON

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 ELYSIUM
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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