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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215738
Company: ZHEJIANG POLY PHARM

Products on ANDA 215738

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUCONAZOLE	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215738

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215738

FLUCONAZOLE

FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIFLUCAN	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	Yes	AB	020090	PFIZER
FLUCONAZOLE	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	079150	AUROBINDO PHARMA
FLUCONAZOLE	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	215738	ZHEJIANG POLY PHARM

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