Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072302
Company: ALVOGEN MALTA
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
05/31/1990 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
01/08/2001 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

06/15/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/15/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/16/1997 SUPPL-9 Labeling

Label is not available on this site.

07/12/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/19/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/20/1994 SUPPL-6 Labeling

Label is not available on this site.

10/22/1993 SUPPL-5 Labeling

Label is not available on this site.

04/07/1993 SUPPL-4 Labeling

Label is not available on this site.

03/03/1992 SUPPL-3 Labeling

Label is not available on this site.

04/30/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/29/1991 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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