Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073316
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
05/28/1993 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
02/16/2000 SUPPL-7 Labeling

Label is not available on this site.

05/13/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/01/1996 SUPPL-4 Labeling

Label is not available on this site.

05/30/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/30/1994 SUPPL-2 Labeling

Label is not available on this site.

09/08/1993 SUPPL-1 Labeling

Label is not available on this site.

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