Product Details for NDA 021190
BUSPAR (BUSPIRONE HYDROCHLORIDE)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BUSPIRONE HYDROCHLORIDE
Proprietary Name: BUSPAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021190
Product Number: 001
Approval Date: Dec 20, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
BUSPAR (BUSPIRONE HYDROCHLORIDE)
Proprietary Name: BUSPAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021190
Product Number: 001
Approval Date: Dec 20, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BUSPIRONE HYDROCHLORIDE
Proprietary Name: BUSPAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021190
Product Number: 002
Approval Date: Dec 20, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
BUSPAR (BUSPIRONE HYDROCHLORIDE)
Proprietary Name: BUSPAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 7.5MG **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: N021190
Product Number: 002
Approval Date: Dec 20, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BUSPIRONE HYDROCHLORIDE
Proprietary Name: BUSPAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG **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: N021190
Product Number: 003
Approval Date: Dec 20, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
BUSPAR (BUSPIRONE HYDROCHLORIDE)
Proprietary Name: BUSPAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG **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: N021190
Product Number: 003
Approval Date: Dec 20, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BUSPIRONE HYDROCHLORIDE
Proprietary Name: BUSPAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG **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: N021190
Product Number: 004
Approval Date: Dec 20, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: BUSPAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG **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: N021190
Product Number: 004
Approval Date: Dec 20, 2000
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information