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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216554

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AMPICILLIN TRIHYDRATE (AMPICILLIN/AMPICILLIN TRIHYDRATE)
EQ 250MG BASE
Marketing Status: Prescription
Active Ingredient: AMPICILLIN/AMPICILLIN TRIHYDRATE
Proprietary Name: AMPICILLIN TRIHYDRATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 250MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A216554
Product Number: 001
Approval Date: Oct 31, 2023
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
AMPICILLIN TRIHYDRATE (AMPICILLIN/AMPICILLIN TRIHYDRATE)
EQ 500MG BASE
Marketing Status: Prescription
Active Ingredient: AMPICILLIN/AMPICILLIN TRIHYDRATE
Proprietary Name: AMPICILLIN TRIHYDRATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 500MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216554
Product Number: 002
Approval Date: Oct 31, 2023
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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