Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065266
Company: WOCKHARDT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET;ORAL Prescription AB No No
CLARITHROMYCIN CLARITHROMYCIN 500MG 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
05/31/2006 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
09/17/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

CLARITHROMYCIN

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET;ORAL Prescription No AB 065489 AUROBINDO
CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET;ORAL Prescription No AB 065384 CHARTWELL
CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET;ORAL Prescription No AB 203584 HEC PHARM
CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET;ORAL Prescription No AB 065178 HIKMA
CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET;ORAL Prescription No AB 065144 SANDOZ
CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET;ORAL Prescription No AB 202710 STRIDES PHARMA
CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET;ORAL Prescription No AB 065155 TEVA
CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET;ORAL Prescription No AB 065266 WOCKHARDT

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET;ORAL Prescription No AB 065489 AUROBINDO
CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET;ORAL Prescription No AB 065384 CHARTWELL
CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET;ORAL Prescription No AB 203584 HEC PHARM
CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET;ORAL Prescription No AB 065178 HIKMA
CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET;ORAL Prescription No AB 065136 SANDOZ
CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET;ORAL Prescription No AB 202710 STRIDES PHARMA
CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET;ORAL Prescription No AB 065155 TEVA
CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET;ORAL Prescription No AB 065266 WOCKHARDT

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