Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074072
Company: PLIVA
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
08/01/1996 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
08/23/2001 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/20/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1999 SUPPL-7 Labeling

Label is not available on this site.

07/13/1999 SUPPL-6 Labeling

Label is not available on this site.

12/03/1998 SUPPL-5 Labeling

Label is not available on this site.

05/08/1998 SUPPL-4 Labeling

Label is not available on this site.

01/20/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/14/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/27/1997 SUPPL-1 Labeling

Label is not available on this site.

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