Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074052
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription AB 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
05/01/1992 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
11/03/2014 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

11/30/2011 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

08/28/2008 SUPPL-37 Labeling

Label is not available on this site.

04/11/2007 SUPPL-34 Labeling

Label is not available on this site.

04/19/2002 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/2002 SUPPL-27 Labeling

Label is not available on this site.

03/22/2002 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/22/2002 SUPPL-25 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/22/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/2001 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/08/2001 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/13/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/2000 SUPPL-18 Labeling

Label is not available on this site.

12/07/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/2000 SUPPL-15 Labeling

Label is not available on this site.

04/27/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/27/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/01/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/26/1997 SUPPL-10 Labeling

Label is not available on this site.

03/01/1996 SUPPL-9 Labeling

Label is not available on this site.

03/22/1995 SUPPL-8 Labeling

Label is not available on this site.

01/24/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/08/1993 SUPPL-6 Labeling

Label is not available on this site.

05/27/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/12/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/07/1993 SUPPL-3 Labeling

Label is not available on this site.

10/28/1992 SUPPL-2 Labeling

Label is not available on this site.

08/28/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ATENOLOL

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 073646 ALVOGEN MALTA
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 078512 AUROBINDO PHARMA
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 077877 IPCA LABS LTD
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 073457 MYLAN
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 074052 SANDOZ
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 078210 SUN PHARM INDS INC
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 074499 SUN PHARM INDUSTRIES
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 074056 TEVA
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 077443 UNIQUE PHARM LABS
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 076900 ZYDUS PHARMS USA
TENORMIN ATENOLOL 25MG TABLET;ORAL Prescription Yes AB 018240 ALVOGEN MALTA

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