FDA.reportPublic FDA data

Application 212587

Type
ANDA
Sponsor
GUARDIAN DRUG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATECAPSULE;ORAL20MG;1.1GMNoNo
002OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATECAPSULE;ORAL40MG;1.1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53041-663Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateGuardian Drug CompanyANDACurrent
53041-663Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateGuardian Drug CompanyANDACurrent
53041-663Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateGuardian Drug CompanyANDACurrent
53041-664Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateGuardian Drug CompanyANDACurrent
53041-664Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateGuardian Drug CompanyANDACurrent
53041-664Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateGuardian Drug CompanyANDACurrent
63629-2490Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateBryant Ranch PrepackANDACurrent
63629-2490Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateBryant Ranch PrepackANDACurrent
63629-2490Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateBryant Ranch PrepackANDACurrent
63629-2491Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateBryant Ranch PrepackANDACurrent
63629-2491Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateBryant Ranch PrepackANDACurrent
63629-2491Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateBryant Ranch PrepackANDACurrent
69784-700Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateWoodward Pharma Services LLCANDACurrent
69784-700Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateWoodward Pharma Services LLCANDACurrent
69784-700Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateWoodward Pharma Services LLCANDACurrent
69784-701Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateWoodward Pharma Services LLCANDACurrent
69784-701Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateWoodward Pharma Services LLCANDACurrent
69784-701Omeprazole, Sodium bicarbonateOmeprazole, Sodium bicarbonateWoodward Pharma Services LLCANDACurrent