Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018062
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROVENTIL ALBUTEROL SULFATE EQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None Yes No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
01/19/1983 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-19 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

11/06/1998 SUPPL-16 Labeling

Label is not available on this site.

09/09/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/27/1993 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/19/1986 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/08/1986 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

04/12/1985 SUPPL-4 Efficacy

Label is not available on this site.

05/16/1985 SUPPL-2 Labeling

Label is not available on this site.

05/16/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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