Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019810

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PRILOSEC (OMEPRAZOLE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: OMEPRAZOLE
Proprietary Name: PRILOSEC
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019810
Product Number: 003
Approval Date: Oct 5, 1995
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

PRILOSEC (OMEPRAZOLE)
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: OMEPRAZOLE
Proprietary Name: PRILOSEC
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019810
Product Number: 001
Approval Date: Sep 14, 1989
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

PRILOSEC (OMEPRAZOLE)
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: OMEPRAZOLE
Proprietary Name: PRILOSEC
Dosage Form; Route of Administration: CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019810
Product Number: 002
Approval Date: Jan 15, 1998
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

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