Details for New Drug Application (NDA): 204762
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NDA 204762 describes DANTROLENE SODIUM, which is a drug marketed by Elite Labs Inc, Impax Labs, Eugia Pharma Speclts, and Hikma, and is included in four NDAs. It is available from eight suppliers. Additional details are available on the DANTROLENE SODIUM profile page.
The generic ingredient in DANTROLENE SODIUM 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 DANTROLENE SODIUM 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 204762
| Tradename: | DANTROLENE SODIUM |
| Applicant: | Hikma |
| Ingredient: | dantrolene sodium |
| Patents: | 0 |
Pharmacology for NDA: 204762
| Physiological Effect | Decreased Striated Muscle Contraction Decreased Striated Muscle Tone |
Medical Subject Heading (MeSH) Categories for 204762
Suppliers and Packaging for NDA: 204762
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DANTROLENE SODIUM | dantrolene sodium | INJECTABLE;INJECTION | 204762 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9297 | 0143-9297-01 | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9297-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/VIAL | ||||
| Approval Date: | Jun 19, 2017 | TE: | AP | RLD: | No | ||||
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