Product Details for NDA 016721
DALMANE (FLURAZEPAM HYDROCHLORIDE)
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLURAZEPAM HYDROCHLORIDE
Proprietary Name: DALMANE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016721
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: VALEANT PHARMACEUTICALS INTERNATIONAL
Marketing Status: Discontinued
Patent and Exclusivity Information
DALMANE (FLURAZEPAM HYDROCHLORIDE)
Proprietary Name: DALMANE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016721
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: VALEANT PHARMACEUTICALS INTERNATIONAL
Marketing Status: Discontinued
Patent and Exclusivity Information
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLURAZEPAM HYDROCHLORIDE
Proprietary Name: DALMANE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N016721
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: VALEANT PHARMACEUTICALS INTERNATIONAL
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DALMANE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N016721
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: VALEANT PHARMACEUTICALS INTERNATIONAL
Marketing Status: Discontinued
Patent and Exclusivity Information