Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019009
Company: BAUSCH
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
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.

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

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