Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077615

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DIVALPROEX SODIUM (DIVALPROEX SODIUM)
EQ 125MG VALPROIC ACID
Marketing Status: Prescription

Active Ingredient: DIVALPROEX SODIUM
Proprietary Name: DIVALPROEX SODIUM
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 125MG VALPROIC ACID
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077615
Product Number: 003
Approval Date: Jul 29, 2008
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DIVALPROEX SODIUM (DIVALPROEX SODIUM)
EQ 250MG VALPROIC ACID
Marketing Status: Prescription

Active Ingredient: DIVALPROEX SODIUM
Proprietary Name: DIVALPROEX SODIUM
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 250MG VALPROIC ACID
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077615
Product Number: 002
Approval Date: Jul 29, 2008
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DIVALPROEX SODIUM (DIVALPROEX SODIUM)
EQ 500MG VALPROIC ACID
Marketing Status: Prescription

Active Ingredient: DIVALPROEX SODIUM
Proprietary Name: DIVALPROEX SODIUM
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 500MG VALPROIC ACID
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077615
Product Number: 001
Approval Date: Jul 29, 2008
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information