Details for New Drug Application (NDA): 211635
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NDA 211635 describes VALTOCO, which is a drug marketed by Neurelis Inc 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 VALTOCO profile page.
The generic ingredient in VALTOCO is diazepam. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the diazepam profile page.
The generic ingredient in VALTOCO is diazepam. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the diazepam profile page.
Summary for 211635
| Tradename: | VALTOCO |
| Applicant: | Neurelis Inc |
| Ingredient: | diazepam |
| Patents: | 8 |
Suppliers and Packaging for NDA: 211635
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALTOCO | diazepam | SPRAY;NASAL | 211635 | NDA | Neurelis, Inc | 72252-505 | 72252-505-02 | 2 BLISTER PACK in 1 CARTON (72252-505-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE |
| VALTOCO | diazepam | SPRAY;NASAL | 211635 | NDA | Neurelis, Inc | 72252-505 | 72252-505-05 | 5 BLISTER PACK in 1 CARTON (72252-505-05) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .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: | Jan 10, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 10, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE ACUTE TX 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 6 YEARS OF AGE AND OLDER | ||||||||
| Regulatory Exclusivity Expiration: | Apr 15, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | 11,241,414 | Patent Expiration: | Mar 27, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 211635
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Neurelis Inc | VALTOCO | diazepam | SPRAY;NASAL | 211635-002 | Jan 10, 2020 | 8,927,497 | ⤷ Start Trial |
| Neurelis Inc | VALTOCO | diazepam | SPRAY;NASAL | 211635-002 | Jan 10, 2020 | 10,265,402 | ⤷ Start Trial |
| Neurelis Inc | VALTOCO | diazepam | SPRAY;NASAL | 211635-002 | Jan 10, 2020 | 9,642,913 | ⤷ Start Trial |
| Neurelis Inc | VALTOCO | diazepam | SPRAY;NASAL | 211635-001 | Jan 10, 2020 | 10,265,402 | ⤷ Start Trial |
| Neurelis Inc | VALTOCO | diazepam | SPRAY;NASAL | 211635-003 | Jan 10, 2020 | 8,927,497 | ⤷ Start Trial |
| Neurelis Inc | VALTOCO | diazepam | SPRAY;NASAL | 211635-003 | Jan 10, 2020 | 9,642,913 | ⤷ Start Trial |
| Neurelis Inc | VALTOCO | diazepam | SPRAY;NASAL | 211635-001 | Jan 10, 2020 | 9,642,913 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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