Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017853
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROVENTIL ALBUTEROL SULFATE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
PROVENTIL ALBUTEROL SULFATE EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
05/07/1982 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
08/12/1999 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/1998 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1998 SUPPL-16 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-15 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

01/24/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/08/1986 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/24/1985 SUPPL-7 Labeling

Label is not available on this site.

12/24/1985 SUPPL-6 Labeling

Label is not available on this site.

12/04/1984 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1986 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/24/1985 SUPPL-1 Labeling

Label is not available on this site.

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