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Details for New Drug Application (NDA): 079182
NDA 079182 describes OMEPRAZOLE AND SODIUM BICARBONATE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Par Pharm, Perrigo R And D, Sciegen Pharms Inc, and Zydus Pharms Usa Inc, and is included in thirteen NDAs. It is available from twenty 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 twenty-six drug master file entries for this compound. Twenty-five 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 twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.
Summary for 079182
| Tradename: | OMEPRAZOLE AND SODIUM BICARBONATE |
| Applicant: | Par Pharm |
| Ingredient: | omeprazole; sodium bicarbonate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 079182
| Mechanism of Action | Proton Pump Inhibitors Cytochrome P450 2C19 Inhibitors |
Suppliers and Packaging for NDA: 079182
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 079182 | ANDA | Par Pharmaceutical, Inc. | 49884-268 | N | 49884-268-11 |
| OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 079182 | ANDA | Par Pharmaceutical, Inc. | 49884-269 | N | 49884-269-11 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 20MG/PACKET;1.68GM/PACKET | ||||
| Approval Date: | Apr 19, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 40MG/PACKET;1.68GM/PACKET | ||||
| Approval Date: | Apr 19, 2013 | TE: | AB | RLD: | No | ||||
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