Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075410

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OMEPRAZOLE (OMEPRAZOLE)
10MG
Marketing Status: Prescription

Active Ingredient: OMEPRAZOLE
Proprietary Name: OMEPRAZOLE
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075410
Product Number: 001
Approval Date: Nov 1, 2002
Applicant Holder Full Name: LANNETT CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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: A075410
Product Number: 002
Approval Date: Nov 1, 2002
Applicant Holder Full Name: LANNETT CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OMEPRAZOLE (OMEPRAZOLE)
40MG
Marketing Status: Prescription

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: AB
Application Number: A075410
Product Number: 003
Approval Date: Jan 23, 2009
Applicant Holder Full Name: LANNETT CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information