Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076686

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DANTROLENE SODIUM (DANTROLENE SODIUM)
25MG
Marketing Status: Prescription

Active Ingredient: DANTROLENE SODIUM
Proprietary Name: DANTROLENE SODIUM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076686
Product Number: 001
Approval Date: Oct 24, 2005
Applicant Holder Full Name: ELITE LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DANTROLENE SODIUM (DANTROLENE SODIUM)
50MG
Marketing Status: Prescription

Active Ingredient: DANTROLENE SODIUM
Proprietary Name: DANTROLENE SODIUM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076686
Product Number: 002
Approval Date: Oct 24, 2005
Applicant Holder Full Name: ELITE LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DANTROLENE SODIUM (DANTROLENE SODIUM)
100MG
Marketing Status: Prescription

Active Ingredient: DANTROLENE SODIUM
Proprietary Name: DANTROLENE SODIUM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076686
Product Number: 003
Approval Date: Oct 24, 2005
Applicant Holder Full Name: ELITE LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information