Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074126
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATENOLOL ATENOLOL 50MG TABLET;ORAL Discontinued None No No
ATENOLOL ATENOLOL 100MG TABLET;ORAL Discontinued None No No
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
03/23/1994 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
10/13/2000 SUPPL-10 Labeling

Label is not available on this site.

08/26/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/26/1998 SUPPL-8 Labeling

Label is not available on this site.

08/26/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/26/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/26/1998 SUPPL-5 Manufacturing (CMC)-New Strength

Label is not available on this site.

08/16/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/13/1994 SUPPL-2 Labeling

Label is not available on this site.

08/29/1994 SUPPL-1 Labeling

Label is not available on this site.

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