Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072152
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET;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
03/23/1989 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/19/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1998 SUPPL-13 Labeling

Label is not available on this site.

11/05/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/07/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/23/1994 SUPPL-10 Labeling

Label is not available on this site.

01/24/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/23/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/23/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/23/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/06/1993 SUPPL-4 Labeling

Label is not available on this site.

07/10/1991 SUPPL-3 Labeling

Label is not available on this site.

09/10/1990 SUPPL-2 Labeling

Label is not available on this site.

10/18/1989 SUPPL-1 Labeling

Label is not available on this site.

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