Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090372
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZAFIRLUKAST ZAFIRLUKAST 10MG TABLET;ORAL Prescription AB No No
ZAFIRLUKAST ZAFIRLUKAST 20MG 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
11/18/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090372s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/07/2014 SUPPL-2 Labeling-Patient Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

09/27/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

ZAFIRLUKAST

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACCOLATE ZAFIRLUKAST 10MG TABLET;ORAL Prescription Yes AB 020547 PAR PHARM INC
ZAFIRLUKAST ZAFIRLUKAST 10MG TABLET;ORAL Prescription No AB 090372 DR REDDYS LABS LTD

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACCOLATE ZAFIRLUKAST 20MG TABLET;ORAL Prescription Yes AB 020547 PAR PHARM INC
ZAFIRLUKAST ZAFIRLUKAST 20MG TABLET;ORAL Prescription No AB 090372 DR REDDYS LABS LTD

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