Application Information

This drug has been submitted to the FDA under the reference 022032/001.

Names and composition

"OMEPRAZOLE" is the commercial name of a drug composed of OMEPRAZOLE.
It belongs to the class Proton pump inhibitors and is used in Peptic ulcer, Z-E syndrome (Gastrointestinal Tract)

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
022032/001 OMEPRAZOLE OMEPRAZOLE TABLET, DELAYED RELEASE/ORAL 20MG
075347/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
075347/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
075347/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
075410/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
075410/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
075410/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
075576/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
075576/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
075576/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
075757/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
075757/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
075785/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
075785/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
075785/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
075791/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ ORAL 10MG
075791/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ ORAL 20MG
075876/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
075876/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
075876/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
076048/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
076048/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
076048/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
076515/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
078490/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
078490/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
078490/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
091352/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
091352/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
091352/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
091672/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
091672/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
091672/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
202384/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
203270/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
203270/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
203270/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
203481/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
203481/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
203481/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
204661/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
204661/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
209400/001 OMEPRAZOLE OMEPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE/ORAL 20MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
019810/001 PRILOSEC OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
019810/002 PRILOSEC OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
019810/003 PRILOSEC OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
022032/001 OMEPRAZOLE OMEPRAZOLE TABLET, DELAYED RELEASE/ORAL 20MG
075347/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
075347/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
075347/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
075410/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
075410/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
075410/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
075576/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
075576/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
075576/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
075757/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
075757/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
075785/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
075785/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
075785/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
075791/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ ORAL 10MG
075791/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ ORAL 20MG
075876/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
075876/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
075876/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
076048/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
076048/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
076048/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
076515/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
078490/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
078490/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
078490/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
091352/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
091352/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
091352/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
091672/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
091672/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
091672/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
202384/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
203270/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
203270/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
203270/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
203481/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 10MG
203481/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
203481/003 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
204661/001 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 20MG
204661/002 OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED REL PELLETS/ORAL 40MG
209400/001 OMEPRAZOLE OMEPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE/ORAL 20MG

Manufacturers

Manufacturer name
AstraZeneca UK Ltd
Discovery Pharmaceuticals

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