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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 061996

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FULVICIN P/G (GRISEOFULVIN, ULTRAMICROSIZE)
125MG
Marketing Status: Prescription
Active Ingredient: GRISEOFULVIN, ULTRAMICROSIZE
Proprietary Name: FULVICIN P/G
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 125MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A061996
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
FULVICIN P/G (GRISEOFULVIN, ULTRAMICROSIZE)
250MG
Marketing Status: Prescription
Active Ingredient: GRISEOFULVIN, ULTRAMICROSIZE
Proprietary Name: FULVICIN P/G
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A061996
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 P/G 165 (GRISEOFULVIN, ULTRAMICROSIZE)
165MG
Marketing Status: Prescription
Active Ingredient: GRISEOFULVIN, ULTRAMICROSIZE
Proprietary Name: FULVICIN P/G 165
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 165MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A061996
Product Number: 003
Approval Date: Apr 6, 1982
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
FULVICIN P/G 330 (GRISEOFULVIN, ULTRAMICROSIZE)
330MG
Marketing Status: Prescription
Active Ingredient: GRISEOFULVIN, ULTRAMICROSIZE
Proprietary Name: FULVICIN P/G 330
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 330MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A061996
Product Number: 004
Approval Date: Apr 6, 1982
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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