Drugs@FDA: FDA Approved Drug Products

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

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 204652 NOVEL LABS INC
FLUCYTOSINE FLUCYTOSINE 250MG CAPSULE;ORAL Prescription No AB 207536 RECIPHARM
FLUCYTOSINE FLUCYTOSINE 250MG CAPSULE;ORAL Prescription No AB 201566 SIGMAPHARM LABS LLC
FLUCYTOSINE FLUCYTOSINE 250MG CAPSULE;ORAL Prescription No AB 206550 WEST-WARD PHARMS INT

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 204652 NOVEL LABS INC
FLUCYTOSINE FLUCYTOSINE 500MG CAPSULE;ORAL Prescription No AB 207536 RECIPHARM
FLUCYTOSINE FLUCYTOSINE 500MG CAPSULE;ORAL Prescription No AB 201566 SIGMAPHARM LABS LLC
FLUCYTOSINE FLUCYTOSINE 500MG CAPSULE;ORAL Prescription No AB 206550 WEST-WARD PHARMS INT

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