FDA.reportPublic FDA data

Application 207476

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

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
42291-585Omeprazole/BicarbonateOmeprazole and Sodium BicarbonateAvKAREANDACurrent
42291-585Omeprazole/BicarbonateOmeprazole and Sodium BicarbonateAvKARE, Inc.ANDACurrent
50228-363Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateScieGen Pharmaceuticals, Inc.ANDACurrent
50228-363Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateScieGen Pharmaceuticals, Inc.ANDACurrent
50228-363Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateScieGen Pharmaceuticals, Inc.ANDACurrent
50228-363Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateScieGen Pharmaceuticals, Inc.ANDACurrent
50228-363Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateScieGen Pharmaceuticals, Inc.ANDACurrent
50228-364Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateScieGen Pharmaceuticals, Inc.ANDACurrent
50228-364Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateScieGen Pharmaceuticals, Inc.ANDACurrent
50228-364Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateScieGen Pharmaceuticals, Inc.ANDACurrent
50228-364Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateScieGen Pharmaceuticals, Inc.ANDACurrent
50228-364Omeprazole and Sodium BicarbonateOmeprazole and Sodium BicarbonateScieGen Pharmaceuticals, Inc.ANDACurrent
69097-913omeprazole sodium bicarbonateomeprazole sodium bicarbonateCipla USA Inc.ANDACurrent
69097-913omeprazole sodium bicarbonateomeprazole sodium bicarbonateCipla USA Inc.ANDACurrent
69097-914omeprazole sodium bicarbonateomeprazole sodium bicarbonateCipla USA Inc.ANDACurrent
69097-914omeprazole sodium bicarbonateomeprazole sodium bicarbonateCipla USA Inc.ANDACurrent
69336-112Not Applicableomeprazole sodium bicarbonateSterling Knight Pharmaceuticals LLCANDACurrent
69367-195Omeprazole/BicarbonateOmeprazole and Sodium BicarbonateWestminster Pharmaceuticals, LLCANDACurrent
69367-195Omeprazole/BicarbonateOmeprazole and Sodium BicarbonateWestminster Pharmaceuticals, LLCANDACurrent
69367-195Omeprazole/BicarbonateOmeprazole and Sodium BicarbonateWestminster Pharmaceuticals, LLCANDACurrent
69367-195Omeprazole/BicarbonateOmeprazole and Sodium BicarbonateWestminster Pharmaceuticals, LLCANDACurrent
69367-195Omeprazole/BicarbonateOmeprazole and Sodium BicarbonateWestminster Pharmaceuticals, LLCANDACurrent
69367-196Omeprazole/BicarbonateOmeprazole and Sodium BicarbonateWestminster Pharmaceuticals, LLCANDACurrent
69367-196Omeprazole/BicarbonateOmeprazole and Sodium BicarbonateWestminster Pharmaceuticals, LLCANDACurrent
69367-196Omeprazole/BicarbonateOmeprazole and Sodium BicarbonateWestminster Pharmaceuticals, LLCANDACurrent
69367-196Omeprazole/BicarbonateOmeprazole and Sodium BicarbonateWestminster Pharmaceuticals, LLCANDACurrent
69367-196Omeprazole/BicarbonateOmeprazole and Sodium BicarbonateWestminster Pharmaceuticals, LLCANDACurrent
71205-984Omeprazole/BicarbonateOmeprazole and Sodium BicarbonateProficient Rx LPANDACurrent
71205-985Omeprazole/BicarbonateOmeprazole and Sodium BicarbonateProficient Rx LPANDACurrent
71399-2420omeprazole sodium bicarbonateomeprazole sodium bicarbonateAkron Pharma IncANDACurrent
71399-2440omeprazole sodium bicarbonateomeprazole sodium bicarbonateAkron Pharma IncANDACurrent