Details for New Drug Application (NDA): 205579
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The generic ingredient in RYANODEX is dantrolene sodium. There are five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.
Summary for 205579
Tradename: | RYANODEX |
Applicant: | Eagle Pharms |
Ingredient: | dantrolene sodium |
Patents: | 5 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205579
Physiological Effect | Decreased Striated Muscle Contraction Decreased Striated Muscle Tone |
Medical Subject Heading (MeSH) Categories for 205579
Suppliers and Packaging for NDA: 205579
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579 | NDA | Eagle Pharmaceuticals, Inc. | 42367-540 | 42367-540-32 | 1 VIAL in 1 CARTON (42367-540-32) > 20 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;INTRAVENOUS | Strength | 250MG/VIAL | ||||
Approval Date: | Jul 22, 2014 | TE: | RLD: | Yes | |||||
Patent: | See Plans and Pricing | Patent Expiration: | Jul 1, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | See Plans and Pricing | Patent Expiration: | Dec 24, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | See Plans and Pricing | Patent Expiration: | Dec 24, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? |
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