Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021726

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NIRAVAM (ALPRAZOLAM)
0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: ALPRAZOLAM
Proprietary Name: NIRAVAM
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021726
Product Number: 001
Approval Date: Jan 19, 2005
Applicant Holder Full Name: UCB INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

NIRAVAM (ALPRAZOLAM)
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: ALPRAZOLAM
Proprietary Name: NIRAVAM
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021726
Product Number: 002
Approval Date: Jan 19, 2005
Applicant Holder Full Name: UCB INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

NIRAVAM (ALPRAZOLAM)
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: ALPRAZOLAM
Proprietary Name: NIRAVAM
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021726
Product Number: 003
Approval Date: Jan 19, 2005
Applicant Holder Full Name: UCB INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

NIRAVAM (ALPRAZOLAM)
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: ALPRAZOLAM
Proprietary Name: NIRAVAM
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021726
Product Number: 004
Approval Date: Jan 19, 2005
Applicant Holder Full Name: UCB INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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