Product Details for NDA 022152
STAVZOR (VALPROIC ACID)
125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VALPROIC ACID
Proprietary Name: STAVZOR
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022152
Product Number: 001
Approval Date: Jul 29, 2008
Applicant Holder Full Name: BIONPHARMA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
STAVZOR (VALPROIC ACID)
Proprietary Name: STAVZOR
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022152
Product Number: 001
Approval Date: Jul 29, 2008
Applicant Holder Full Name: BIONPHARMA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VALPROIC ACID
Proprietary Name: STAVZOR
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022152
Product Number: 002
Approval Date: Jul 29, 2008
Applicant Holder Full Name: BIONPHARMA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
STAVZOR (VALPROIC ACID)
Proprietary Name: STAVZOR
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022152
Product Number: 002
Approval Date: Jul 29, 2008
Applicant Holder Full Name: BIONPHARMA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: VALPROIC ACID
Proprietary Name: STAVZOR
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022152
Product Number: 003
Approval Date: Jul 29, 2008
Applicant Holder Full Name: BIONPHARMA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: STAVZOR
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022152
Product Number: 003
Approval Date: Jul 29, 2008
Applicant Holder Full Name: BIONPHARMA INC
Marketing Status: Discontinued
Patent and Exclusivity Information