Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073533
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.083% BASE 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
09/26/1995 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
01/25/2002 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

04/03/2001 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/17/2000 SUPPL-13 Labeling

Label is not available on this site.

08/17/2000 SUPPL-12 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/17/2000 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/21/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/23/1998 SUPPL-8 Labeling

Label is not available on this site.

07/16/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/16/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/16/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/16/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/16/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/16/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/28/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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