Details for New Drug Application (NDA): 076686
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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 |
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 | Elite Laboratories, Inc. | 64850-840 | 64850-840-01 | 100 CAPSULE in 1 BOTTLE (64850-840-01) |
DANTROLENE SODIUM | dantrolene sodium | CAPSULE;ORAL | 076686 | ANDA | Elite Laboratories, Inc. | 64850-841 | 64850-841-01 | 100 CAPSULE in 1 BOTTLE (64850-841-01) |
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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