Details for New Drug Application (NDA): 218637
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NDA 218637 describes RALDESY, which is a drug marketed by Kamat and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the RALDESY profile page.
The generic ingredient in RALDESY is trazodone hydrochloride. There are fourteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.
The generic ingredient in RALDESY is trazodone hydrochloride. There are fourteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.
Summary for 218637
| Tradename: | RALDESY |
| Applicant: | Kamat |
| Ingredient: | trazodone hydrochloride |
| Patents: | 1 |
Suppliers and Packaging for NDA: 218637
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RALDESY | trazodone hydrochloride | SOLUTION;ORAL | 218637 | NDA | Validus Pharmaceuticals LLC | 30698-455 | 30698-455-01 | 300 mL in 1 BOTTLE (30698-455-01) |
| RALDESY | trazodone hydrochloride | SOLUTION;ORAL | 218637 | NDA | Validus Pharmaceuticals LLC | 30698-455 | 30698-455-02 | 150 mL in 1 BOTTLE (30698-455-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | Nov 26, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Mar 13, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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