Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050785

AUGMENTIN XR (AMOXICILLIN; CLAVULANATE POTASSIUM)
1GM;EQ 62.5MG BASE Marketing Status: Prescription

Active Ingredient: AMOXICILLIN; CLAVULANATE POTASSIUM
Proprietary Name: AUGMENTIN XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1GM;EQ 62.5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N050785
Product Number: 001
Approval Date: Sep 25, 2002
Applicant Holder Full Name: DR REDDYS LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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