Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065384
Company: CHARTWELL
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
08/20/2007 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
07/27/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

07/27/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

07/27/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

03/06/2013 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

07/18/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/06/2008 SUPPL-4 Labeling

Label is not available on this site.

07/16/2008 SUPPL-2 Labeling

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 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 065178 WEST-WARD PHARMS INT
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 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 065178 WEST-WARD PHARMS INT
CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET;ORAL Prescription No AB 065266 WOCKHARDT

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