Details for New Drug Application (NDA): 201361
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NDA 201361 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 201361
| Tradename: | OMEPRAZOLE AND SODIUM BICARBONATE |
| Applicant: | Perrigo R And D |
| Ingredient: | omeprazole; sodium bicarbonate |
| Patents: | 0 |
Pharmacology for NDA: 201361
| 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: 201361
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 201361 | ANDA | L. Perrigo Company | 0113-0058 | 0113-0058-03 | 3 BOTTLE in 1 CARTON (0113-0058-03) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE |
| OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | CAPSULE;ORAL | 201361 | ANDA | Walgreen Company | 0363-0732 | 0363-0732-03 | 3 BOTTLE in 1 CARTON (0363-0732-03) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE;ORAL | Strength | 20MG;1.1GM | ||||
| Approval Date: | Jul 15, 2016 | TE: | RLD: | No | |||||
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