Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018340
Company: ROCHE PALO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AEROBID FLUNISOLIDE 0.25MG/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
08/17/1984 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
11/26/2003 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18340slr021ltr.pdf
05/08/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/05/1994 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1994 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1993 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/19/1992 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/06/1989 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/23/1987 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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