Details for New Drug Application (NDA): 207476
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NDA 207476 describes OMEPRAZOLE AND SODIUM BICARBONATE, which is a drug marketed by Ajanta Pharma Ltd, Anda Repository, Aurobindo Pharma, Aurolife Pharma Llc, Chartwell Rx, Dr Reddys, Perrigo R And D, Sciegen Pharms Inc, Strides Pharma, Zydus, and Zydus Pharms, and is included in fifteen NDAs. It is available from twenty-four suppliers. Additional details are available on the OMEPRAZOLE AND SODIUM BICARBONATE profile page.
The generic ingredient in OMEPRAZOLE AND SODIUM BICARBONATE is omeprazole; sodium bicarbonate. There are one hundred and thirty-one drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.
The generic ingredient in OMEPRAZOLE AND SODIUM BICARBONATE is omeprazole; sodium bicarbonate. There are one hundred and thirty-one drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.
Summary for 207476
| Tradename: | OMEPRAZOLE AND SODIUM BICARBONATE |
| Applicant: | Sciegen Pharms Inc |
| Ingredient: | omeprazole; sodium bicarbonate |
| Patents: | 0 |
Pharmacology for NDA: 207476
| Mechanism of Action | Alkalinizing Activity Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 207476
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 207476 | ANDA | ScieGen Pharmaceuticals, Inc. | 50228-363 | 50228-363-05 | 500 CAPSULE in 1 BOTTLE (50228-363-05) |
| OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 207476 | ANDA | ScieGen Pharmaceuticals, Inc. | 50228-363 | 50228-363-30 | 30 CAPSULE in 1 BOTTLE (50228-363-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG;1.1GM | ||||
| Approval Date: | Dec 6, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 40MG;1.1GM | ||||
| Approval Date: | Dec 6, 2016 | TE: | AB | RLD: | No | ||||
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