Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 050580

Expand all

AZACTAM (AZTREONAM)
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)
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)
500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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