Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090289
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LETROZOLE LETROZOLE 2.5MG 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
06/03/2011 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
02/13/2015 SUPPL-3 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

02/13/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

LETROZOLE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FEMARA LETROZOLE 2.5MG TABLET;ORAL Prescription Yes AB 020726 NOVARTIS PHARMS
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 090934 ACCORD HLTHCARE
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 091303 APOTEX INC
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 205869 BEIJING YILING
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 091191 DR REDDYS LABS LTD
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 211717 EUGIA PHARMA
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 090491 FRESENIUS KABI USA
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 203796 HIKMA PHARMS
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 201804 INDICUS PHARMA
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 202716 JIANGSU HENGRUI MED
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 200161 NATCO PHARMA LTD
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 090289 TEVA PHARMS
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 090789 VINTAGE PHARMS LLC
LETROZOLE LETROZOLE 2.5MG TABLET;ORAL Prescription No AB 090838 WEST-WARD PHARMS INT

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