Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074203
Company: MYLAN
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
10/31/1993 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
07/31/2015 SUPPL-23 Labeling-Container/Carton Labels

Label is not available on this site.

03/20/2009 SUPPL-18 Labeling

Label is not available on this site.

12/12/2005 SUPPL-11 Labeling

Label is not available on this site.

02/06/2004 SUPPL-10 Labeling

Label is not available on this site.

10/22/2003 SUPPL-9 Labeling

Label is not available on this site.

08/22/2002 SUPPL-8 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

08/14/2000 SUPPL-7 Labeling

Label is not available on this site.

06/07/2000 SUPPL-6 Labeling

Label is not available on this site.

12/28/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/03/1997 SUPPL-3 Labeling

Label is not available on this site.

09/18/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/31/1994 SUPPL-1 Labeling

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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