Details for New Drug Application (NDA): 210833
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NDA 210833 describes SYMPAZAN, which is a drug marketed by Assertio Speclty and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the SYMPAZAN profile page.
The generic ingredient in SYMPAZAN is clobazam. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the clobazam profile page.
The generic ingredient in SYMPAZAN is clobazam. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the clobazam profile page.
Summary for 210833
| Tradename: | SYMPAZAN |
| Applicant: | Assertio Speclty |
| Ingredient: | clobazam |
| Patents: | 3 |
Pharmacology for NDA: 210833
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
Suppliers and Packaging for NDA: 210833
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYMPAZAN | clobazam | FILM;ORAL | 210833 | NDA | Aquestive Therapeutics | 10094-205 | 10094-205-60 | 60 POUCH in 1 PACKAGE (10094-205-60) / 1 FILM in 1 POUCH (10094-205-01) |
| SYMPAZAN | clobazam | FILM;ORAL | 210833 | NDA | Aquestive Therapeutics | 10094-210 | 10094-210-60 | 60 POUCH in 1 PACKAGE (10094-210-60) / 1 FILM in 1 POUCH (10094-210-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 1, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jan 31, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING SEIZURES | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Sep 5, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING SEIZURES | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Sep 5, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING SEIZURES | ||||||||
Expired US Patents for NDA 210833
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Assertio Speclty | SYMPAZAN | clobazam | FILM;ORAL | 210833-002 | Nov 1, 2018 | ⤷ Get Started Free | ⤷ Get Started Free |
| Assertio Speclty | SYMPAZAN | clobazam | FILM;ORAL | 210833-001 | Nov 1, 2018 | ⤷ Get Started Free | ⤷ Get Started Free |
| Assertio Speclty | SYMPAZAN | clobazam | FILM;ORAL | 210833-002 | Nov 1, 2018 | ⤷ Get Started Free | ⤷ Get Started Free |
| Assertio Speclty | SYMPAZAN | clobazam | FILM;ORAL | 210833-003 | Nov 1, 2018 | ⤷ Get Started Free | ⤷ Get Started Free |
| Assertio Speclty | SYMPAZAN | clobazam | FILM;ORAL | 210833-001 | Nov 1, 2018 | ⤷ Get Started Free | ⤷ Get Started Free |
| Assertio Speclty | SYMPAZAN | clobazam | FILM;ORAL | 210833-003 | Nov 1, 2018 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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