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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017105

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TRANXENE (CLORAZEPATE DIPOTASSIUM)
7.5MG
Marketing Status: Prescription
Active Ingredient: CLORAZEPATE DIPOTASSIUM
Proprietary Name: TRANXENE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N017105
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: KEY THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
TRANXENE (CLORAZEPATE DIPOTASSIUM)
3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLORAZEPATE DIPOTASSIUM
Proprietary Name: TRANXENE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017105
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: KEY THERAPEUTICS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TRANXENE (CLORAZEPATE DIPOTASSIUM)
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLORAZEPATE DIPOTASSIUM
Proprietary Name: TRANXENE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017105
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: KEY THERAPEUTICS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TRANXENE (CLORAZEPATE DIPOTASSIUM)
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLORAZEPATE DIPOTASSIUM
Proprietary Name: TRANXENE
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: N017105
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: KEY THERAPEUTICS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TRANXENE (CLORAZEPATE DIPOTASSIUM)
3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLORAZEPATE DIPOTASSIUM
Proprietary Name: TRANXENE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3.75MG **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: N017105
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: KEY THERAPEUTICS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TRANXENE (CLORAZEPATE DIPOTASSIUM)
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLORAZEPATE DIPOTASSIUM
Proprietary Name: TRANXENE
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: Yes
Reference Standard: No
TE Code: 
Application Number: N017105
Product Number: 008
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: KEY THERAPEUTICS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TRANXENE SD (CLORAZEPATE DIPOTASSIUM)
11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLORAZEPATE DIPOTASSIUM
Proprietary Name: TRANXENE SD
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 11.25MG **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: N017105
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: KEY THERAPEUTICS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TRANXENE SD (CLORAZEPATE DIPOTASSIUM)
22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLORAZEPATE DIPOTASSIUM
Proprietary Name: TRANXENE SD
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 22.5MG **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: N017105
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: KEY THERAPEUTICS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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