Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019009
Company: BAUSCH

Products on NDA 019009

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAXAIR	PIRBUTEROL ACETATE	EQ 0.2MG BASE/INH	AEROSOL, METERED;INHALATION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019009

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/1986	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019009Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/17/2001	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/14/2001	SUPPL-6	Manufacturing (CMC)-Control	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19009s6lbl.pdf
02/11/1998	SUPPL-5	Labeling		Label is not available on this site.
11/22/1993	SUPPL-4	Labeling		Label is not available on this site.
08/19/1991	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 019009

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/14/2001	SUPPL-6	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19009s6lbl.pdf