Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077731
Company: AUROBINDO PHARMA
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
10/07/2008 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
07/08/2019 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

07/08/2019 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

07/08/2019 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

07/08/2019 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

01/29/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/29/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/29/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/23/2012 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

12/01/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

10/13/2011 SUPPL-3 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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