Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072316
Company: PLIVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET;ORAL 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
01/30/1989 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
07/07/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

05/20/1998 SUPPL-9 Labeling

Label is not available on this site.

08/01/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/05/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/22/1995 SUPPL-6 Labeling

Label is not available on this site.

05/17/1994 SUPPL-5 Labeling

Label is not available on this site.

05/17/1994 SUPPL-4 Labeling

Label is not available on this site.

05/11/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/04/1992 SUPPL-2 Labeling

Label is not available on this site.

01/16/1991 SUPPL-1 Labeling

Label is not available on this site.

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