Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019383
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROVENTIL ALBUTEROL SULFATE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL 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
07/13/1987 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
04/09/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/18/1997 SUPPL-11 Efficacy-New Indication

Label is not available on this site.

11/06/1998 SUPPL-10 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/17559-S023_Proventil.pdf
05/24/1999 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/27/1993 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/1997 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/1992 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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