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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018716

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TRANDATE (LABETALOL HYDROCHLORIDE)
100MG
Marketing Status: Discontinued
Active Ingredient: LABETALOL HYDROCHLORIDE
Proprietary Name: TRANDATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018716
Product Number: 001
Approval Date: May 24, 1985
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TRANDATE (LABETALOL HYDROCHLORIDE)
200MG
Marketing Status: Discontinued
Active Ingredient: LABETALOL HYDROCHLORIDE
Proprietary Name: TRANDATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018716
Product Number: 002
Approval Date: Aug 1, 1984
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TRANDATE (LABETALOL HYDROCHLORIDE)
300MG
Marketing Status: Discontinued
Active Ingredient: LABETALOL HYDROCHLORIDE
Proprietary Name: TRANDATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N018716
Product Number: 003
Approval Date: Aug 1, 1984
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TRANDATE (LABETALOL HYDROCHLORIDE)
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: LABETALOL HYDROCHLORIDE
Proprietary Name: TRANDATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018716
Product Number: 004
Approval Date: Aug 1, 1984
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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