Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050632

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AZACTAM IN PLASTIC CONTAINER (AZTREONAM)
10MG/ML
Marketing Status: Discontinued

Active Ingredient: AZTREONAM
Proprietary Name: AZACTAM IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050632
Product Number: 003
Approval Date: May 24, 1989
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

AZACTAM IN PLASTIC CONTAINER (AZTREONAM)
20MG/ML
Marketing Status: Discontinued

Active Ingredient: AZTREONAM
Proprietary Name: AZACTAM IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050632
Product Number: 002
Approval Date: May 24, 1989
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

AZACTAM IN PLASTIC CONTAINER (AZTREONAM)
40MG/ML
Marketing Status: Discontinued

Active Ingredient: AZTREONAM
Proprietary Name: AZACTAM IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40MG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050632
Product Number: 001
Approval Date: May 24, 1989
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information