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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215560
Company: NOVITIUM PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 50MG;25MG TABLET;ORAL Prescription AB No No
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
10/25/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

ATENOLOL AND CHLORTHALIDONE

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
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 50MG;25MG TABLET;ORAL Prescription No AB 215560 NOVITIUM PHARMA
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 50MG;25MG TABLET;ORAL Prescription No AB 213302 UNICHEM
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 ALMATICA

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
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 100MG;25MG TABLET;ORAL Prescription No AB 215560 NOVITIUM PHARMA
ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 100MG;25MG TABLET;ORAL Prescription No AB 213302 UNICHEM
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 ALMATICA
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