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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 061212

BACITRACIN (BACITRACIN)
500 UNITS/GM
Marketing Status: Prescription
Active Ingredient: BACITRACIN
Proprietary Name: BACITRACIN
Dosage Form; Route of Administration: OINTMENT; OPHTHALMIC
Strength: 500 UNITS/GM
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A061212
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PADAGIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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