An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213665
Company: AUROBINDO PHARMA LTD

Products on ANDA 213665

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 213665

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213665

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

Top