Product Details for NDA 050580
AZACTAM (AZTREONAM)
1GM/VIAL
Marketing Status: Prescription
2GM/VIAL
Marketing Status: Prescription
500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1GM/VIAL
Marketing Status: Prescription
Active Ingredient: AZTREONAM
Proprietary Name: AZACTAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N050580
Product Number: 002
Approval Date: Dec 31, 1986
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Prescription
Patent and Exclusivity Information
AZACTAM (AZTREONAM)
Proprietary Name: AZACTAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N050580
Product Number: 002
Approval Date: Dec 31, 1986
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Prescription
Patent and Exclusivity Information
2GM/VIAL
Marketing Status: Prescription
Active Ingredient: AZTREONAM
Proprietary Name: AZACTAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2GM/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N050580
Product Number: 003
Approval Date: Dec 31, 1986
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Prescription
Patent and Exclusivity Information
AZACTAM (AZTREONAM)
Proprietary Name: AZACTAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2GM/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N050580
Product Number: 003
Approval Date: Dec 31, 1986
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Prescription
Patent and Exclusivity Information
500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AZTREONAM
Proprietary Name: AZACTAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050580
Product Number: 001
Approval Date: Dec 31, 1986
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: AZACTAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050580
Product Number: 001
Approval Date: Dec 31, 1986
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status: Discontinued
Patent and Exclusivity Information