Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011665
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MESTINON PYRIDOSTIGMINE BROMIDE 180MG TABLET, EXTENDED RELEASE;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
01/12/1959 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
07/25/2014 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/03/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/14/2001 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/13/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/07/1996 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/2001 SUPPL-15 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf
10/24/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/26/2001 SUPPL-13 Labeling

Label is not available on this site.

07/18/1989 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/1986 SUPPL-10 Labeling

Label is not available on this site.

11/22/1978 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/16/1978 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1977 SUPPL-5 Manufacturing (CMC)-Control

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-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/15193s18lbl.pdf

MESTINON

TABLET, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MESTINON PYRIDOSTIGMINE BROMIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 011665 BAUSCH
PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204737 ALVOGEN
PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203184 IMPAX LABS INC
PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE 180MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205464 RISING

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