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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072273
Company: ARMSTRONG PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL 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
08/14/1996 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
04/29/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/2001 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

06/27/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

09/18/2000 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1999 SUPPL-11 Labeling

Label is not available on this site.

02/19/1999 SUPPL-10 Labeling

Label is not available on this site.

08/06/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/06/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/05/1999 SUPPL-6 Labeling

Label is not available on this site.

04/30/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/15/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/05/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/04/1996 SUPPL-2 Labeling

Label is not available on this site.

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