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Details for New Drug Application (NDA): 079182
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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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