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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011665
Company: BAUSCH

Products on NDA 011665

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011665

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.

Labels for NDA 011665

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

Therapeutic Equivalents for NDA 011665

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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