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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204661

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OMEPRAZOLE (OMEPRAZOLE)
20MG
Marketing Status: Prescription
Active Ingredient: OMEPRAZOLE
Proprietary Name: OMEPRAZOLE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204661
Product Number: 001
Approval Date: Jun 13, 2017
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
OMEPRAZOLE (OMEPRAZOLE)
40MG
Marketing Status: Discontinued
Active Ingredient: OMEPRAZOLE
Proprietary Name: OMEPRAZOLE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A204661
Product Number: 002
Approval Date: Jun 13, 2017
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information
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