Details for New Drug Application (NDA): 219161
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NDA 219161 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, Strides Pharma Intl, Zydus, Zydus Pharms, and Novitium Pharma, and is included in sixteen NDAs. It is available from twenty-one 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-four 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-four suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.
Summary for 219161
| Tradename: | OMEPRAZOLE AND SODIUM BICARBONATE |
| Applicant: | Novitium Pharma |
| Ingredient: | omeprazole; sodium bicarbonate |
| Patents: | 0 |
Pharmacology for NDA: 219161
| Mechanism of Action | Alkalinizing Activity Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 219161
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 219161 | ANDA | ANI Pharmaceuticals, Inc. | 70954-797 | 70954-797-20 | 30 PACKET in 1 CARTON (70954-797-20) / 1 POWDER, FOR SUSPENSION in 1 PACKET (70954-797-10) |
| OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 219161 | ANDA | ANI Pharmaceuticals, Inc. | 70954-798 | 70954-798-20 | 30 PACKET in 1 CARTON (70954-798-20) / 1 POWDER, FOR SUSPENSION in 1 PACKET (70954-798-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 20MG/PACKET;1.68GM/PACKET | ||||
| Approval Date: | Dec 10, 2025 | 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: | Dec 10, 2025 | TE: | AB | RLD: | No | ||||
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