Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073272
Company: IVAX SUB TEVA 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
12/28/1995 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
10/22/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

08/18/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/17/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/15/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/22/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/16/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/16/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-1 Labeling

Label is not available on this site.

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