Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065439

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AZTREONAM (AZTREONAM)
500MG/VIAL
Marketing Status: Prescription
Active Ingredient: AZTREONAM
Proprietary Name: AZTREONAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 500MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A065439
Product Number: 001
Approval Date: Jun 18, 2010
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
AZTREONAM (AZTREONAM)
1GM/VIAL
Marketing Status: Prescription
Active Ingredient: AZTREONAM
Proprietary Name: AZTREONAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A065439
Product Number: 002
Approval Date: Jun 18, 2010
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
AZTREONAM (AZTREONAM)
2GM/VIAL
Marketing Status: Prescription
Active Ingredient: AZTREONAM
Proprietary Name: AZTREONAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2GM/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A065439
Product Number: 003
Approval Date: Jun 18, 2010
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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