Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017588

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GLEOSTINE (LOMUSTINE)
10MG
Marketing Status: Prescription

Active Ingredient: LOMUSTINE
Proprietary Name: GLEOSTINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N017588
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: CORDEN PHARMA LATINA SPA
Marketing Status:  Prescription
Patent and Exclusivity Information

GLEOSTINE (LOMUSTINE)
40MG
Marketing Status: Prescription

Active Ingredient: LOMUSTINE
Proprietary Name: GLEOSTINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N017588
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: CORDEN PHARMA LATINA SPA
Marketing Status:  Prescription
Patent and Exclusivity Information

GLEOSTINE (LOMUSTINE)
100MG
Marketing Status: Prescription

Active Ingredient: LOMUSTINE
Proprietary Name: GLEOSTINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N017588
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: CORDEN PHARMA LATINA SPA
Marketing Status:  Prescription
Patent and Exclusivity Information

GLEOSTINE (LOMUSTINE)
5MG
Marketing Status: Discontinued

Active Ingredient: LOMUSTINE
Proprietary Name: GLEOSTINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N017588
Product Number: 004
Approval Date: Dec 19, 2014
Applicant Holder Full Name: CORDEN PHARMA LATINA SPA
Marketing Status:  Discontinued
Patent and Exclusivity Information