Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022056

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PRILOSEC (OMEPRAZOLE MAGNESIUM)
EQ 2.5MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: OMEPRAZOLE MAGNESIUM
Proprietary Name: PRILOSEC
Dosage Form; Route of Administration: FOR SUSPENSION, DELAYED RELEASE; ORAL
Strength: EQ 2.5MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022056
Product Number: 001
Approval Date: Mar 20, 2008
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
PRILOSEC (OMEPRAZOLE MAGNESIUM)
EQ 10MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: OMEPRAZOLE MAGNESIUM
Proprietary Name: PRILOSEC
Dosage Form; Route of Administration: FOR SUSPENSION, DELAYED RELEASE; ORAL
Strength: EQ 10MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022056
Product Number: 002
Approval Date: Mar 20, 2008
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information

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