Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076900
Company: ZYDUS PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription AB No No
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription AB No No
ATENOLOL ATENOLOL 100MG 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
01/28/2005 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
10/31/2014 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

09/13/2011 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

01/14/2009 SUPPL-18 Labeling

Label is not available on this site.

08/29/2008 SUPPL-17 Labeling

Label is not available on this site.

02/19/2009 SUPPL-12 Labeling

Label is not available on this site.

02/19/2009 SUPPL-11 Labeling

Label is not available on this site.

02/19/2009 SUPPL-9 Labeling

Label is not available on this site.

03/01/2007 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/2007 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/2007 SUPPL-3 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/17/2006 SUPPL-2 Labeling

Label is not available on this site.

ATENOLOL

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 073646 ALVOGEN MALTA
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 078512 AUROBINDO PHARMA
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 074052 SANDOZ
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 078210 SUN PHARM INDS INC
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 074499 SUN PHARM INDUSTRIES
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 MALTA

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 072303 ALVOGEN MALTA
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 077877 IPCA LABS LTD
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 073457 MYLAN
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 073025 SANDOZ
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 078210 SUN PHARM INDS INC
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 073475 SUN PHARM INDUSTRIES
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 MALTA

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 MALTA
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 077877 IPCA LABS LTD
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 073457 MYLAN
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 073026 SANDOZ
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 078210 SUN PHARM INDS INC
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 073476 SUN PHARM INDUSTRIES
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 MALTA

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