Details for New Drug Application (NDA): 213593
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NDA 213593 describes KONVOMEP, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the KONVOMEP profile page.
The generic ingredient in KONVOMEP is omeprazole; sodium bicarbonate. There are one hundred and thirty-one drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.
The generic ingredient in KONVOMEP is omeprazole; sodium bicarbonate. There are one hundred and thirty-one drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.
Summary for 213593
| Tradename: | KONVOMEP |
| Applicant: | Azurity |
| Ingredient: | omeprazole; sodium bicarbonate |
| Patents: | 8 |
Suppliers and Packaging for NDA: 213593
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KONVOMEP | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 213593 | NDA | Azurity Pharmaceuticals, Inc. | 65628-272 | 65628-272-03 | 1 KIT in 1 CARTON (65628-272-03) * 150 mL in 1 BOTTLE (65628-270-05) * 300 mL in 1 BOTTLE (65628-270-10) * 150 mL in 1 BOTTLE (65628-271-05) * 300 mL in 1 BOTTLE (65628-271-10) * 90 mL in 1 BOTTLE (65628-271-03) * 90 mL in 1 BOTTLE (65628-270-03) |
| KONVOMEP | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 213593 | NDA | Azurity Pharmaceuticals, Inc. | 65628-272 | 65628-272-05 | 1 KIT in 1 CARTON (65628-272-05) * 150 mL in 1 BOTTLE (65628-270-05) * 300 mL in 1 BOTTLE (65628-270-10) * 150 mL in 1 BOTTLE (65628-271-05) * 300 mL in 1 BOTTLE (65628-271-10) * 90 mL in 1 BOTTLE (65628-271-03) * 90 mL in 1 BOTTLE (65628-270-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 2MG/ML;84MG/ML | ||||
| Approval Date: | Aug 30, 2022 | TE: | RLD: | Yes | |||||
| Patent: | 10,751,333 | Patent Expiration: | Jul 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,103,492 | Patent Expiration: | Jul 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,633,478 | Patent Expiration: | Jul 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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