Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074099
Company: DAVA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATENOLOL ATENOLOL 25MG 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
04/28/1992 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
09/14/2005 SUPPL-21 Labeling

Label is not available on this site.

05/21/2001 SUPPL-19 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/05/2000 SUPPL-16 Labeling

Label is not available on this site.

05/24/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/05/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/30/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/30/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/18/1997 SUPPL-10 Labeling

Label is not available on this site.

06/10/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/15/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/15/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/08/1994 SUPPL-6 Labeling

Label is not available on this site.

10/04/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/13/1993 SUPPL-4 Labeling

Label is not available on this site.

01/14/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/04/1993 SUPPL-2 Labeling

Label is not available on this site.

09/25/1992 SUPPL-1 Labeling

Label is not available on this site.

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