Product Details for NDA 015539
SERAX (OXAZEPAM)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: OXAZEPAM
Proprietary Name: SERAX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N015539
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ALPHARMA US PHARMACEUTICALS DIVISION
Marketing Status: Discontinued
Patent and Exclusivity Information
SERAX (OXAZEPAM)
Proprietary Name: SERAX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N015539
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ALPHARMA US PHARMACEUTICALS DIVISION
Marketing Status: Discontinued
Patent and Exclusivity Information
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: OXAZEPAM
Proprietary Name: SERAX
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Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: Yes
Reference Standard: No
TE Code:
Application Number: N015539
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ALPHARMA US PHARMACEUTICALS DIVISION
Marketing Status: Discontinued
Patent and Exclusivity Information
SERAX (OXAZEPAM)
Proprietary Name: SERAX
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: Yes
Reference Standard: No
TE Code:
Application Number: N015539
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ALPHARMA US PHARMACEUTICALS DIVISION
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: OXAZEPAM
Proprietary Name: SERAX
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: N015539
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ALPHARMA US PHARMACEUTICALS DIVISION
Marketing Status: Discontinued
Patent and Exclusivity Information
SERAX (OXAZEPAM)
Proprietary Name: SERAX
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: N015539
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ALPHARMA US PHARMACEUTICALS DIVISION
Marketing Status: Discontinued
Patent and Exclusivity Information
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: OXAZEPAM
Proprietary Name: SERAX
Dosage Form; Route of Administration: TABLET; 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: N015539
Product Number: 008
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ALPHARMA US PHARMACEUTICALS DIVISION
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: SERAX
Dosage Form; Route of Administration: TABLET; 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: N015539
Product Number: 008
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ALPHARMA US PHARMACEUTICALS DIVISION
Marketing Status: Discontinued
Patent and Exclusivity Information