Product Details for NDA 021567
REYATAZ (ATAZANAVIR SULFATE)
EQ 200MG BASE
Marketing Status: Prescription
EQ 300MG BASE
Marketing Status: Prescription
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 200MG BASE
Marketing Status: Prescription
Active Ingredient: ATAZANAVIR SULFATE
Proprietary Name: REYATAZ
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021567
Product Number: 003
Approval Date: Jun 20, 2003
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Prescription
Patent and Exclusivity Information
REYATAZ (ATAZANAVIR SULFATE)
Proprietary Name: REYATAZ
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021567
Product Number: 003
Approval Date: Jun 20, 2003
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 300MG BASE
Marketing Status: Prescription
Active Ingredient: ATAZANAVIR SULFATE
Proprietary Name: REYATAZ
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021567
Product Number: 004
Approval Date: Oct 16, 2006
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Prescription
Patent and Exclusivity Information
REYATAZ (ATAZANAVIR SULFATE)
Proprietary Name: REYATAZ
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021567
Product Number: 004
Approval Date: Oct 16, 2006
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ATAZANAVIR SULFATE
Proprietary Name: REYATAZ
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 100MG BASE **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: N021567
Product Number: 001
Approval Date: Jun 20, 2003
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information
REYATAZ (ATAZANAVIR SULFATE)
Proprietary Name: REYATAZ
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 100MG BASE **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: N021567
Product Number: 001
Approval Date: Jun 20, 2003
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ATAZANAVIR SULFATE
Proprietary Name: REYATAZ
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 150MG BASE **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: N021567
Product Number: 002
Approval Date: Jun 20, 2003
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: REYATAZ
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 150MG BASE **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: N021567
Product Number: 002
Approval Date: Jun 20, 2003
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status: Discontinued
Patent and Exclusivity Information