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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065403

AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM; SULBACTAM SODIUM)
EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: AMPICILLIN SODIUM; SULBACTAM SODIUM
Proprietary Name: AMPICILLIN AND SULBACTAM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A065403
Product Number: 001
Approval Date: Dec 23, 2009
Applicant Holder Full Name: ACS DOBFAR SPA
Marketing Status:  Prescription
Patent and Exclusivity Information
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