Details for New Drug Application (NDA): 217784
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NDA 217784 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 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 is one drug master file entry for this compound. Twenty-three 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 is one drug master file entry for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.
Summary for 217784
| Tradename: | OMEPRAZOLE AND SODIUM BICARBONATE |
| Applicant: | Dr Reddys |
| Ingredient: | omeprazole; sodium bicarbonate |
| Patents: | 0 |
Pharmacology for NDA: 217784
| Mechanism of Action | Alkalinizing Activity Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 217784
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 217784 | ANDA | Dr. Reddy's Laboratories Inc., | 43598-010 | 43598-010-01 | 1 PACKET in 1 CARTON (43598-010-01) / 1 POWDER, FOR SUSPENSION in 1 PACKET |
| OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 217784 | ANDA | Dr. Reddy's Laboratories Inc., | 43598-010 | 43598-010-14 | 14 PACKET in 1 CARTON (43598-010-14) / 1 POWDER, FOR SUSPENSION in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FOR SUSPENSION;ORAL | Strength | 20MG/PACKET;1.68GM/PACKET | ||||
| Approval Date: | May 9, 2024 | TE: | RLD: | No | |||||
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