Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 015193
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MESTINON PYRIDOSTIGMINE BROMIDE 60MG/5ML SYRUP;ORAL Prescription AA 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
01/25/1965 ORIG-1 Approval Type 3 - New Dosage Form 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
02/23/2015 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/26/2013 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/30/2014 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/22/2002 SUPPL-20 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/15193s020ltr.pdf
11/07/1996 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/2001 SUPPL-18 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf
10/27/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/17/1993 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/1986 SUPPL-14 Labeling

Label is not available on this site.

02/04/1982 SUPPL-12 Manufacturing (CMC)-Packaging

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-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf

MESTINON

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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