Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018760
Company: ALVOGEN MALTA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TENORETIC 100 ATENOLOL; CHLORTHALIDONE 100MG;25MG TABLET;ORAL Prescription AB Yes Yes
TENORETIC 50 ATENOLOL; CHLORTHALIDONE 50MG;25MG TABLET;ORAL Prescription AB Yes 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
06/08/1984 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2012 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018760s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018760Orig1s029ltr.pdf
08/21/2011 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018760s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018760s028ltr.pdf
10/29/2008 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018760s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018760s027ltr.pdf
02/09/2005 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18760s026ltr.pdf
10/30/2003 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18760slr025ltr.pdf
01/31/2003 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18760slr024ltr.pdf
07/21/1999 SUPPL-23 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18240-s026_tenormin.pdf
04/04/2000 SUPPL-22 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18240-s025_Tenormin.pdf
10/11/1996 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/09/1996 SUPPL-20 Labeling

Label is not available on this site.

05/04/1994 SUPPL-18 Labeling

Label is not available on this site.

06/04/1993 SUPPL-17 Labeling

Label is not available on this site.

04/29/1993 SUPPL-16 Labeling

Label is not available on this site.

08/05/1992 SUPPL-15 Labeling

Label is not available on this site.

08/05/1992 SUPPL-14 Labeling

Label is not available on this site.

09/18/1991 SUPPL-13 Labeling

Label is not available on this site.

04/26/1991 SUPPL-12 Labeling

Label is not available on this site.

04/26/1991 SUPPL-11 Labeling

Label is not available on this site.

04/26/1991 SUPPL-10 Labeling

Label is not available on this site.

01/08/1987 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/20/1985 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/19/1985 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/17/1985 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/08/1985 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1984 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1984 SUPPL-2 Labeling

Label is not available on this site.

08/13/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/31/2012 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018760s029lbl.pdf
08/21/2011 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018760s028lbl.pdf
10/29/2008 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018760s027lbl.pdf

TENORETIC 100

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
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 100MG;25MG TABLET;ORAL Prescription No AB 210028 ZYDUS PHARMS
TENORETIC 100 ATENOLOL; CHLORTHALIDONE 100MG;25MG TABLET;ORAL Prescription Yes AB 018760 ALVOGEN MALTA

TENORETIC 50

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 072302 ALVOGEN MALTA
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 073582 SUN PHARM INDUSTRIES
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 50MG;25MG TABLET;ORAL Prescription No AB 073665 WATSON LABS
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 50MG;25MG TABLET;ORAL Prescription No AB 210028 ZYDUS PHARMS
TENORETIC 50 ATENOLOL; CHLORTHALIDONE 50MG;25MG TABLET;ORAL Prescription Yes AB 018760 ALVOGEN MALTA

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