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Details for New Drug Application (NDA): 079182
» See Plans and Pricing
NDA 079182 describes OMEPRAZOLE AND SODIUM BICARBONATE, which is a drug marketed by Ajanta Pharma Ltd, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Guardian Drug, Par Pharm, Perrigo R And D, Sciegen Pharms Inc, Unicorn, and Zydus Pharms, and is included in fourteen 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 thirty-one drug master file entries 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 are one hundred and thirty-one drug master file entries for this compound. Twenty-three 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 |
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 | 49884-268-11 | 30 PACKET in 1 CARTON (49884-268-11) > 1 POWDER, FOR SUSPENSION in 1 PACKET (49884-268-52) |
| OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 079182 | ANDA | Par Pharmaceutical, Inc. | 49884-269 | 49884-269-11 | 30 PACKET in 1 CARTON (49884-269-11) > 1 POWDER, FOR SUSPENSION in 1 PACKET (49884-269-52) |
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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