Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 061931

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AMOXICILLIN (AMOXICILLIN)
250MG/5ML
Marketing Status: Prescription

Active Ingredient: AMOXICILLIN
Proprietary Name: AMOXICILLIN
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 250MG/5ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A061931
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AMOXICILLIN PEDIATRIC (AMOXICILLIN)
50MG/ML
Marketing Status: Prescription

Active Ingredient: AMOXICILLIN
Proprietary Name: AMOXICILLIN PEDIATRIC
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 50MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A061931
Product Number: 003
Approval Date: Dec 1, 1982
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AMOXICILLIN (AMOXICILLIN)
125MG/5ML
Marketing Status: Discontinued

Active Ingredient: AMOXICILLIN
Proprietary Name: AMOXICILLIN
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 125MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A061931
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information