Details for New Drug Application (NDA): 219428
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NDA 219428 describes TONMYA, which is a drug marketed by Tonix 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 TONMYA profile page.
The generic ingredient in TONMYA is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
The generic ingredient in TONMYA is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
Summary for 219428
| Tradename: | TONMYA |
| Applicant: | Tonix |
| Ingredient: | cyclobenzaprine hydrochloride |
| Patents: | 4 |
Pharmacology for NDA: 219428
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 219428
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TONMYA | cyclobenzaprine hydrochloride | TABLET;SUBLINGUAL | 219428 | NDA | Tonix Medicines, Inc. | 70792-102 | 70792-102-14 | 14 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-14) |
| TONMYA | cyclobenzaprine hydrochloride | TABLET;SUBLINGUAL | 219428 | NDA | Tonix Medicines, Inc. | 70792-102 | 70792-102-30 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 2.8MG | ||||
| Approval Date: | Aug 15, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 15, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 10,117,936 | Patent Expiration: | Mar 14, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,864,175 | Patent Expiration: | Mar 14, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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