Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204652

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FLUCYTOSINE (FLUCYTOSINE)
250MG
Marketing Status: Prescription

Active Ingredient: FLUCYTOSINE
Proprietary Name: FLUCYTOSINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204652
Product Number: 001
Approval Date: Jul 7, 2017
Applicant Holder Full Name: NOVEL LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FLUCYTOSINE (FLUCYTOSINE)
500MG
Marketing Status: Prescription

Active Ingredient: FLUCYTOSINE
Proprietary Name: FLUCYTOSINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204652
Product Number: 002
Approval Date: Jul 7, 2017
Applicant Holder Full Name: NOVEL LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information