Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077652

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LEVOFLOXACIN (LEVOFLOXACIN)
250MG
Marketing Status: Prescription

Active Ingredient: LEVOFLOXACIN
Proprietary Name: LEVOFLOXACIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077652
Product Number: 001
Approval Date: Sep 7, 2012
Applicant Holder Full Name: ZYDUS LIFESCIENCES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LEVOFLOXACIN (LEVOFLOXACIN)
500MG
Marketing Status: Prescription

Active Ingredient: LEVOFLOXACIN
Proprietary Name: LEVOFLOXACIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077652
Product Number: 002
Approval Date: Sep 7, 2012
Applicant Holder Full Name: ZYDUS LIFESCIENCES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LEVOFLOXACIN (LEVOFLOXACIN)
750MG
Marketing Status: Prescription

Active Ingredient: LEVOFLOXACIN
Proprietary Name: LEVOFLOXACIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 750MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077652
Product Number: 003
Approval Date: Sep 7, 2012
Applicant Holder Full Name: ZYDUS LIFESCIENCES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information