Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073665
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 50MG;25MG TABLET;ORAL Prescription AB No No
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
07/02/1992 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
06/11/2015 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

05/26/2006 SUPPL-18 Labeling

Label is not available on this site.

03/19/2004 SUPPL-15 Labeling

Label is not available on this site.

04/09/2001 SUPPL-14 Labeling

Label is not available on this site.

04/25/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/2000 SUPPL-12 Labeling

Label is not available on this site.

09/07/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/07/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/13/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/08/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/11/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/14/1996 SUPPL-5 Labeling

Label is not available on this site.

01/19/1995 SUPPL-4 Labeling

Label is not available on this site.

02/16/1994 SUPPL-3 Labeling

Label is not available on this site.

11/10/1992 SUPPL-2 Labeling

Label is not available on this site.

01/07/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ATENOLOL AND CHLORTHALIDONE

TABLET;ORAL; 50MG;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 50MG;25MG TABLET;ORAL Prescription No AB 072301 ALVOGEN MALTA
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 50MG;25MG TABLET;ORAL Prescription No AB 073581 MUTUAL PHARM
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 50MG;25MG TABLET;ORAL Prescription No AB 074203 MYLAN
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 50MG;25MG TABLET;ORAL Prescription No AB 073665 WATSON LABS
TENORETIC 50 ATENOLOL; CHLORTHALIDONE 50MG;25MG TABLET;ORAL Prescription Yes AB 018760 ALVOGEN MALTA

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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