Details for New Drug Application (NDA): 078378
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NDA 078378 describes REVONTO, which is a drug marketed by Uswm and is included in one NDA. It is available from two suppliers. Additional details are available on the REVONTO profile page.
The generic ingredient in REVONTO is dantrolene sodium. There are five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.
The generic ingredient in REVONTO is dantrolene sodium. There are five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.
Summary for 078378
| Tradename: | REVONTO |
| Applicant: | Uswm |
| Ingredient: | dantrolene sodium |
| Patents: | 0 |
Pharmacology for NDA: 078378
| Physiological Effect | Decreased Striated Muscle Contraction Decreased Striated Muscle Tone |
Medical Subject Heading (MeSH) Categories for 078378
Suppliers and Packaging for NDA: 078378
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REVONTO | dantrolene sodium | INJECTABLE;INJECTION | 078378 | ANDA | USWM, LLC | 78670-003 | 78670-003-67 | 6 VIAL, GLASS in 1 CARTON (78670-003-67) / 60 mL in 1 VIAL, GLASS |
| REVONTO | dantrolene sodium | INJECTABLE;INJECTION | 078378 | ANDA | ProPharma Distribution | 84549-003 | 84549-003-67 | 60 mL in 1 VIAL, GLASS (84549-003-67) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/VIAL | ||||
| Approval Date: | Jul 24, 2007 | TE: | AP | RLD: | No | ||||
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