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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 060569

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FULVICIN-U/F (GRISEOFULVIN, MICROSIZE)
250MG
Marketing Status: Prescription
Active Ingredient: GRISEOFULVIN, MICROSIZE
Proprietary Name: FULVICIN-U/F
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A060569
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
FULVICIN-U/F (GRISEOFULVIN, MICROSIZE)
500MG
Marketing Status: Prescription
Active Ingredient: GRISEOFULVIN, MICROSIZE
Proprietary Name: FULVICIN-U/F
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A060569
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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