Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017559
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROVENTIL ALBUTEROL 0.09MG/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
05/01/1981 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/07/2006 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017559s040_ltr.pdf
12/04/2000 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1999 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1998 SUPPL-23 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17559-S023_Proventil.pdf
09/09/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/15/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/24/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/29/1986 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/08/1986 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/22/1986 SUPPL-10 Labeling

Label is not available on this site.

07/02/1985 SUPPL-9 Labeling

Label is not available on this site.

07/02/1985 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/1985 SUPPL-7 Labeling

Label is not available on this site.

02/21/1985 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1984 SUPPL-5 Efficacy

Label is not available on this site.

12/04/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1982 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1981 SUPPL-2 Labeling

Label is not available on this site.

11/02/1981 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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