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Last Updated: November 4, 2024

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 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.
Summary for 076686
Tradename:DANTROLENE SODIUM
Applicant:Elite Labs Inc
Ingredient:dantrolene sodium
Patents:0
Pharmacology for NDA: 076686
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:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Oct 24, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Oct 24, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Oct 24, 2005TE:ABRLD:No

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