Details for New Drug Application (NDA): 211321
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NDA 211321 describes NAYZILAM, which is a drug marketed by Ucb Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the NAYZILAM profile page.
The generic ingredient in NAYZILAM is midazolam. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the midazolam profile page.
The generic ingredient in NAYZILAM is midazolam. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the midazolam profile page.
Suppliers and Packaging for NDA: 211321
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NAYZILAM | midazolam | SPRAY;NASAL | 211321 | NDA | UCB, Inc. | 50474-500 | 50474-500-15 | 2 BLISTER PACK in 1 CARTON (50474-500-15) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (50474-500-14) / .1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | 5MG/SPRAY | ||||
| Approval Date: | May 17, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 17, 2026 | ||||||||
| Regulatory Exclusivity Use: | ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER | ||||||||
| Patent: | 8,217,033 | Patent Expiration: | Jan 18, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER | ||||||||
| Patent: | 8,809,322 | Patent Expiration: | Jan 18, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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