Details for New Drug Application (NDA): 078378
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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 |
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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