Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073582
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 100MG;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
04/29/1993 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
06/30/2015 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

06/30/2015 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.

08/30/2005 SUPPL-28 Labeling

Label is not available on this site.

08/30/2005 SUPPL-27 Labeling

Label is not available on this site.

07/29/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/2000 SUPPL-15 Labeling

Label is not available on this site.

05/16/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

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

Label is not available on this site.

05/14/1997 SUPPL-11 Labeling

Label is not available on this site.

02/24/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/29/1996 SUPPL-9 Labeling

Label is not available on this site.

09/25/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/18/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/15/1995 SUPPL-5 Labeling

Label is not available on this site.

09/16/1994 SUPPL-4 Labeling

Label is not available on this site.

05/23/1994 SUPPL-3 Labeling

Label is not available on this site.

12/22/1993 SUPPL-2 Labeling

Label is not available on this site.

01/12/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ATENOLOL AND CHLORTHALIDONE

TABLET;ORAL; 100MG;25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 100MG;25MG TABLET;ORAL Prescription No AB 072302 ALVOGEN MALTA
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 100MG;25MG TABLET;ORAL Prescription No AB 074203 MYLAN
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 100MG;25MG TABLET;ORAL Prescription No AB 073582 SUN PHARM INDUSTRIES
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 100MG;25MG TABLET;ORAL Prescription No AB 073665 WATSON LABS
TENORETIC 100 ATENOLOL; CHLORTHALIDONE 100MG;25MG TABLET;ORAL Prescription Yes AB 018760 ALVOGEN MALTA

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