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Details for New Drug Application (NDA): 205579
NDA 205579 describes RYANODEX, which is a drug marketed by Eagle Pharms and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the RYANODEX profile page.
The generic ingredient in RYANODEX is dantrolene sodium. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dantrolene sodium profile page.
The generic ingredient in RYANODEX is dantrolene sodium. There are five drug master file entries for this compound. Eight 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 | |||||
| Regulatory Exclusivity Expiration: | Jul 22, 2021 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF MALIGNANT HYPERTHERMIA IN CONJUNCTION WITH APPROPRIATE SUPPORTIVE MEASURES AND FOR THE PREVENTION OF MALIGNANT HYPERTHERMIA IN PATIENTS AT HIGH RISK | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jul 1, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Dec 24, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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