Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072619
Company: TEVA
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
04/07/1989 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
06/12/1998 SUPPL-15 Labeling

Label is not available on this site.

06/18/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/21/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/21/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/15/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/01/1993 SUPPL-6 Labeling

Label is not available on this site.

11/05/1992 SUPPL-4 Labeling

Label is not available on this site.

03/06/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/18/1991 SUPPL-2 Labeling

Label is not available on this site.

01/17/1991 SUPPL-1 Labeling

Label is not available on this site.

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