Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212475
Company: ANNORA PHARMA
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
09/10/2020 ORIG-1 Approval STANDARD

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 STRIDES PHARMA
ZAFIRLUKAST ZAFIRLUKAST 10MG TABLET;ORAL Prescription No AB 212475 ANNORA PHARMA
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 STRIDES PHARMA
ZAFIRLUKAST ZAFIRLUKAST 20MG TABLET;ORAL Prescription No AB 212475 ANNORA PHARMA
ZAFIRLUKAST ZAFIRLUKAST 20MG TABLET;ORAL Prescription No AB 090372 DR REDDYS LABS LTD

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