Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077833
Company: IMPAX LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NADOLOL AND BENDROFLUMETHIAZIDE BENDROFLUMETHIAZIDE; NADOLOL 5MG;40MG TABLET;ORAL Prescription AB No No
NADOLOL AND BENDROFLUMETHIAZIDE BENDROFLUMETHIAZIDE; NADOLOL 5MG;80MG 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
03/30/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077833s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/26/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

NADOLOL AND BENDROFLUMETHIAZIDE

TABLET;ORAL; 5MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORZIDE BENDROFLUMETHIAZIDE; NADOLOL 5MG;40MG TABLET;ORAL Prescription Yes AB 018647 KING PHARMS LLC
NADOLOL AND BENDROFLUMETHIAZIDE BENDROFLUMETHIAZIDE; NADOLOL 5MG;40MG TABLET;ORAL Prescription No AB 077833 IMPAX LABS

TABLET;ORAL; 5MG;80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORZIDE BENDROFLUMETHIAZIDE; NADOLOL 5MG;80MG TABLET;ORAL Prescription Yes AB 018647 KING PHARMS LLC
NADOLOL AND BENDROFLUMETHIAZIDE BENDROFLUMETHIAZIDE; NADOLOL 5MG;80MG TABLET;ORAL Prescription No AB 077833 IMPAX LABS

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