Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074499
Company: SUN PHARM INDUSTRIES
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
07/30/1997 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
04/29/2015 SUPPL-34 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/24/2011 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

03/15/2010 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

08/26/2005 SUPPL-22 Labeling

Label is not available on this site.

05/03/2005 SUPPL-21 Labeling

Label is not available on this site.

07/24/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2000 SUPPL-4 Labeling

Label is not available on this site.

05/16/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

03/25/1998 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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