Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202545

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GRISEOFULVIN,ULTRAMICROSIZE (GRISEOFULVIN, ULTRAMICROSIZE)
125MG
Marketing Status: Prescription

Active Ingredient: GRISEOFULVIN, ULTRAMICROSIZE
Proprietary Name: GRISEOFULVIN,ULTRAMICROSIZE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 125MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202545
Product Number: 001
Approval Date: Oct 22, 2012
Applicant Holder Full Name: SIGMAPHARM LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

GRISEOFULVIN,ULTRAMICROSIZE (GRISEOFULVIN, ULTRAMICROSIZE)
250MG
Marketing Status: Prescription

Active Ingredient: GRISEOFULVIN, ULTRAMICROSIZE
Proprietary Name: GRISEOFULVIN,ULTRAMICROSIZE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202545
Product Number: 002
Approval Date: Oct 22, 2012
Applicant Holder Full Name: SIGMAPHARM LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information