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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091644

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LEVOFLOXACIN (LEVOFLOXACIN)
EQ 500MG/20ML (EQ 25MG/ML)
Marketing Status: Prescription
Active Ingredient: LEVOFLOXACIN
Proprietary Name: LEVOFLOXACIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG/20ML (EQ 25MG/ML)
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A091644
Product Number: 001
Approval Date: Jun 20, 2011
Applicant Holder Full Name: RISING PHARMA HOLDINGS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LEVOFLOXACIN (LEVOFLOXACIN)
EQ 750MG/30ML (EQ 25MG/ML)
Marketing Status: Prescription
Active Ingredient: LEVOFLOXACIN
Proprietary Name: LEVOFLOXACIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 750MG/30ML (EQ 25MG/ML)
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A091644
Product Number: 002
Approval Date: Jun 20, 2011
Applicant Holder Full Name: RISING PHARMA HOLDINGS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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