Details for New Drug Application (NDA): 018264
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The generic ingredient in DANTRIUM 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 018264
Tradename: | DANTRIUM |
Applicant: | Endo Operations |
Ingredient: | dantrolene sodium |
Patents: | 0 |
Pharmacology for NDA: 018264
Physiological Effect | Decreased Striated Muscle Contraction Decreased Striated Muscle Tone |
Medical Subject Heading (MeSH) Categories for 018264
Suppliers and Packaging for NDA: 018264
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DANTRIUM | dantrolene sodium | INJECTABLE;INJECTION | 018264 | NDA | ENDO USA, Inc. | 42023-123 | 42023-123-06 | 6 VIAL in 1 CARTON (42023-123-06) / 60 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/VIAL | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes |
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