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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077443
Company: UNIQUE PHARM LABS
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
09/13/2006 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
11/04/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/28/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

07/06/2010 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

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 072304 ALVOGEN
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 078512 AUROBINDO PHARMA
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 073026 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 213136 UNICHEM
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 ALMATICA

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 073026 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 213136 UNICHEM
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 ALMATICA

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 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 213136 UNICHEM
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 ALMATICA
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