Details for New Drug Application (NDA): 076686
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NDA 076686 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 nine 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 076686
| Tradename: | DANTROLENE SODIUM |
| Applicant: | Elite Labs Inc |
| Ingredient: | dantrolene sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076686
| Physiological Effect | Decreased Striated Muscle Contraction Decreased Striated Muscle Tone |
Medical Subject Heading (MeSH) Categories for 076686
Suppliers and Packaging for NDA: 076686
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DANTROLENE SODIUM | dantrolene sodium | CAPSULE;ORAL | 076686 | ANDA | Lannett Company, Inc. | 0527-3219 | 0527-3219-37 | 100 CAPSULE in 1 BOTTLE (0527-3219-37) |
| DANTROLENE SODIUM | dantrolene sodium | CAPSULE;ORAL | 076686 | ANDA | Lannett Company, Inc. | 0527-3220 | 0527-3220-37 | 100 CAPSULE in 1 BOTTLE (0527-3220-37) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 24, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Oct 24, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Oct 24, 2005 | TE: | AB | RLD: | No | ||||
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