Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074265
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATENOLOL ATENOLOL 25MG TABLET;ORAL Discontinued None No No
ATENOLOL ATENOLOL 50MG TABLET;ORAL Discontinued None No No
ATENOLOL ATENOLOL 100MG 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
02/28/1994 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
01/27/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/08/1997 SUPPL-11 Labeling

Label is not available on this site.

10/21/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/01/1997 SUPPL-9 Labeling

Label is not available on this site.

06/04/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/13/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/13/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/13/1996 SUPPL-5 Labeling

Label is not available on this site.

03/13/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/13/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/02/1994 SUPPL-2 Labeling

Label is not available on this site.

08/01/1994 SUPPL-1 Labeling

Label is not available on this site.

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