Details for New Drug Application (NDA): 076856
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NDA 076856 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 076856
| Tradename: | DANTROLENE SODIUM |
| Applicant: | Impax Labs |
| Ingredient: | dantrolene sodium |
| Patents: | 0 |
Pharmacology for NDA: 076856
| Physiological Effect | Decreased Striated Muscle Contraction Decreased Striated Muscle Tone |
Medical Subject Heading (MeSH) Categories for 076856
Suppliers and Packaging for NDA: 076856
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DANTROLENE SODIUM | dantrolene sodium | CAPSULE;ORAL | 076856 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-4411 | 0115-4411-01 | 100 CAPSULE in 1 BOTTLE (0115-4411-01) |
| DANTROLENE SODIUM | dantrolene sodium | CAPSULE;ORAL | 076856 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-4411 | 0115-4411-02 | 500 CAPSULE in 1 BOTTLE (0115-4411-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Mar 1, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Mar 1, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Mar 1, 2005 | TE: | AB | RLD: | No | ||||
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