Details for New Drug Application (NDA): 078966
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NDA 078966 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 078966
| Tradename: | OMEPRAZOLE AND SODIUM BICARBONATE |
| Applicant: | Strides Pharma |
| Ingredient: | omeprazole; sodium bicarbonate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 20MG;1.1GM | ||||
| Approval Date: | May 25, 2010 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 40MG;1.1GM | ||||
| Approval Date: | May 25, 2010 | TE: | RLD: | No | |||||
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