Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072652
Company: MYLAN SPECLT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INHALATION Discontinued None No No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
02/21/1992 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
12/08/2011 SUPPL-47 Labeling-Container/Carton Labels

Label is not available on this site.

02/16/2012 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

05/26/2004 SUPPL-27 Labeling

Label is not available on this site.

04/01/2004 SUPPL-24 Labeling

Label is not available on this site.

12/09/2002 SUPPL-21 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/09/2002 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

01/31/2001 SUPPL-18 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/20/2000 SUPPL-17 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

11/17/1999 SUPPL-16 Labeling

Label is not available on this site.

06/23/2000 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

02/29/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/14/1999 SUPPL-12 Labeling

Label is not available on this site.

01/08/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/08/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/24/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/09/1994 SUPPL-8 Labeling

Label is not available on this site.

11/30/1994 SUPPL-5 Labeling

Label is not available on this site.

05/04/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/30/1993 SUPPL-3 Labeling

Label is not available on this site.

03/30/1993 SUPPL-2 Labeling

Label is not available on this site.

10/22/1992 SUPPL-1 Labeling

Label is not available on this site.

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