Details for New Drug Application (NDA): 204922
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NDA 204922 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 204922
| Tradename: | OMEPRAZOLE AND SODIUM BICARBONATE |
| Applicant: | Aurolife Pharma Llc |
| Ingredient: | omeprazole; sodium bicarbonate |
| Patents: | 0 |
Pharmacology for NDA: 204922
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Osmotic Activity Proton Pump Inhibitors |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 204922
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 204922 | ANDA | Medarbor Llc | 69665-216 | 69665-216-30 | 30 CAPSULE in 1 BOTTLE (69665-216-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG;1.1GM | ||||
| Approval Date: | Aug 19, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 40MG;1.1GM | ||||
| Approval Date: | Aug 19, 2016 | TE: | AB | RLD: | No | ||||
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