Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078423
Company: HARRIS PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription AB No No
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription AB No No
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription AB No No
FLUCONAZOLE FLUCONAZOLE 200MG 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
03/07/2011 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
03/10/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

03/14/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

03/14/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

FLUCONAZOLE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIFLUCAN FLUCONAZOLE 50MG TABLET;ORAL Prescription Yes AB 019949 PFIZER
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 077731 AUROBINDO PHARMA
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 076665 CHARTWELL
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 076658 DR REDDYS LABS INC
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 077253 GLENMARK GENERICS
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 078423 HARRIS PHARM
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 076077 IVAX SUB TEVA PHARMS
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 076351 MYLAN
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 076507 TARO
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 074681 TEVA
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 076957 UNIQUE PHARM LABS
FLUCONAZOLE FLUCONAZOLE 50MG TABLET;ORAL Prescription No AB 208963 ZYDUS PHARMS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIFLUCAN FLUCONAZOLE 100MG TABLET;ORAL Prescription Yes AB 019949 PFIZER
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 077731 AUROBINDO PHARMA
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 076665 CHARTWELL
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 076658 DR REDDYS LABS INC
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 077253 GLENMARK GENERICS
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 078423 HARRIS PHARM
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 076077 IVAX SUB TEVA PHARMS
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 076351 MYLAN
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 076507 TARO
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 074681 TEVA
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 076957 UNIQUE PHARM LABS
FLUCONAZOLE FLUCONAZOLE 100MG TABLET;ORAL Prescription No AB 208963 ZYDUS PHARMS

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIFLUCAN FLUCONAZOLE 150MG TABLET;ORAL Prescription Yes AB 019949 PFIZER
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 077731 AUROBINDO PHARMA
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 076665 CHARTWELL
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 076658 DR REDDYS LABS INC
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 077253 GLENMARK GENERICS
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 078423 HARRIS PHARM
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 076077 IVAX SUB TEVA PHARMS
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 076351 MYLAN
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 076507 TARO
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 074681 TEVA
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 076957 UNIQUE PHARM LABS
FLUCONAZOLE FLUCONAZOLE 150MG TABLET;ORAL Prescription No AB 208963 ZYDUS PHARMS

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIFLUCAN FLUCONAZOLE 200MG TABLET;ORAL Prescription Yes AB 019949 PFIZER
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 077731 AUROBINDO PHARMA
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 076665 CHARTWELL
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 076658 DR REDDYS LABS INC
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 077253 GLENMARK GENERICS
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 078423 HARRIS PHARM
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 076077 IVAX SUB TEVA PHARMS
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 076351 MYLAN
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 076507 TARO
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 074681 TEVA
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 076957 UNIQUE PHARM LABS
FLUCONAZOLE FLUCONAZOLE 200MG TABLET;ORAL Prescription No AB 208963 ZYDUS PHARMS

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