Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073475
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATENOLOL ATENOLOL 50MG 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
03/30/1993 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
04/29/2015 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

10/24/2011 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

03/15/2010 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

08/26/2005 SUPPL-25 Labeling

Label is not available on this site.

05/03/2005 SUPPL-24 Labeling

Label is not available on this site.

07/24/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2000 SUPPL-11 Labeling

Label is not available on this site.

05/16/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

12/05/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/25/1996 SUPPL-6 Labeling

Label is not available on this site.

06/22/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/13/1994 SUPPL-4 Labeling

Label is not available on this site.

12/16/1993 SUPPL-3 Labeling

Label is not available on this site.

01/12/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/19/1993 SUPPL-1 Labeling

Label is not available on this site.

ATENOLOL

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 072303 ALVOGEN MALTA
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 078512 AUROBINDO PHARMA
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 073542 DAVA PHARMS INC
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 077877 IPCA LABS LTD
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 073457 MYLAN
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 073025 SANDOZ
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 078210 SUN PHARM INDS INC
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 073475 SUN PHARM INDUSTRIES
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 074056 TEVA
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 077443 UNIQUE PHARM LABS
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 076900 ZYDUS PHARMS USA
TENORMIN ATENOLOL 50MG TABLET;ORAL Prescription Yes AB 018240 ALVOGEN MALTA

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