Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018240
Company: ALVOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TENORMIN ATENOLOL 50MG TABLET;ORAL Prescription AB Yes No
TENORMIN ATENOLOL 100MG TABLET;ORAL Prescription AB Yes Yes
TENORMIN ATENOLOL 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
08/19/1981 ORIG-1 Approval Type 1 - New Molecular Entity 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
09/10/2015 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

09/03/2015 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

08/27/2015 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

07/16/2015 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

07/15/2015 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

07/09/2015 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/31/2012 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018240s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018240Orig1s032ltr.pdf
08/17/2011 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018240s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018240s031ltr.pdf
04/29/2008 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018240s030ltr.pdf
02/09/2005 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18240s029ltr.pdf
11/06/2003 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18240slr028,19058slr016ltr.pdf
01/09/2003 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18240slr027ltr.pdf
07/21/1999 SUPPL-26 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-25 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-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/09/1996 SUPPL-23 Labeling

Label is not available on this site.

05/04/1994 SUPPL-21 Labeling

Label is not available on this site.

04/29/1993 SUPPL-20 Labeling

Label is not available on this site.

08/05/1992 SUPPL-19 Labeling

Label is not available on this site.

08/05/1992 SUPPL-18 Labeling

Label is not available on this site.

09/18/1991 SUPPL-17 Labeling

Label is not available on this site.

02/21/1991 SUPPL-16 Labeling

Label is not available on this site.

02/21/1991 SUPPL-15 Labeling

Label is not available on this site.

02/21/1991 SUPPL-14 Labeling

Label is not available on this site.

04/09/1990 SUPPL-13 Efficacy-New Dosing Regimen

Label is not available on this site.

02/13/1987 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/18/1985 SUPPL-9 Labeling

Label is not available on this site.

11/19/1984 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/15/1983 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1989 SUPPL-5 Efficacy-New Indication

Label is not available on this site.

09/27/1983 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/07/1983 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/04/1985 SUPPL-2 Efficacy-New Indication

Label is not available on this site.

09/23/1981 SUPPL-1 Labeling

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-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018240s032lbl.pdf
08/17/2011 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018240s031lbl.pdf

TENORMIN

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 072304 ALVOGEN
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 078512 AUROBINDO PHARMA
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 073542 DAVA PHARMS INC
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 073025 HLTHCARE
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 077877 IPCA LABS LTD
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 073457 MYLAN
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 074056 TEVA
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 077443 UNIQUE PHARM LABS
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 076900 ZYDUS PHARMS USA
TENORMIN ATENOLOL 50MG TABLET;ORAL Prescription Yes AB 018240 ALVOGEN

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 072304 ALVOGEN
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 078512 AUROBINDO PHARMA
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 073543 DAVA PHARMS INC
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 073026 HLTHCARE
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 077877 IPCA LABS LTD
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 073457 MYLAN
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 074056 TEVA
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 077443 UNIQUE PHARM LABS
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 076900 ZYDUS PHARMS USA
TENORMIN ATENOLOL 100MG TABLET;ORAL Prescription Yes AB 018240 ALVOGEN

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 072304 ALVOGEN
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 078512 AUROBINDO PHARMA
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 074052 HLTHCARE
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 077877 IPCA LABS LTD
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 073457 MYLAN
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 074056 TEVA
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 077443 UNIQUE PHARM LABS
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 076900 ZYDUS PHARMS USA
TENORMIN ATENOLOL 25MG TABLET;ORAL Prescription Yes AB 018240 ALVOGEN

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