Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204652
Company: NOVEL LABS INC

Products on ANDA 204652

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUCYTOSINE	FLUCYTOSINE	250MG	CAPSULE;ORAL	Prescription	AB	No	No
FLUCYTOSINE	FLUCYTOSINE	500MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204652

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/2017	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 204652

FLUCYTOSINE

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANCOBON	FLUCYTOSINE	250MG	CAPSULE;ORAL	Prescription	Yes	AB	017001	BAUSCH
FLUCYTOSINE	FLUCYTOSINE	250MG	CAPSULE;ORAL	Prescription	No	AB	213665	AUROBINDO PHARMA LTD
FLUCYTOSINE	FLUCYTOSINE	250MG	CAPSULE;ORAL	Prescription	No	AB	204652	NOVEL LABS INC
FLUCYTOSINE	FLUCYTOSINE	250MG	CAPSULE;ORAL	Prescription	No	AB	201566	SIGMAPHARM LABS LLC
FLUCYTOSINE	FLUCYTOSINE	250MG	CAPSULE;ORAL	Prescription	No	AB	212632	STRIDES PHARMA

CAPSULE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANCOBON	FLUCYTOSINE	500MG	CAPSULE;ORAL	Prescription	Yes	AB	017001	BAUSCH
FLUCYTOSINE	FLUCYTOSINE	500MG	CAPSULE;ORAL	Prescription	No	AB	213665	AUROBINDO PHARMA LTD
FLUCYTOSINE	FLUCYTOSINE	500MG	CAPSULE;ORAL	Prescription	No	AB	204652	NOVEL LABS INC
FLUCYTOSINE	FLUCYTOSINE	500MG	CAPSULE;ORAL	Prescription	No	AB	201566	SIGMAPHARM LABS LLC
FLUCYTOSINE	FLUCYTOSINE	500MG	CAPSULE;ORAL	Prescription	No	AB	212632	STRIDES PHARMA