Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 016295

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DROXIA (HYDROXYUREA)
200MG
Marketing Status: Prescription

Active Ingredient: HYDROXYUREA
Proprietary Name: DROXIA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N016295
Product Number: 002
Approval Date: Feb 25, 1998
Applicant Holder Full Name: CHEPLAPHARM ARZNEIMITTEL GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information

DROXIA (HYDROXYUREA)
300MG
Marketing Status: Prescription

Active Ingredient: HYDROXYUREA
Proprietary Name: DROXIA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N016295
Product Number: 003
Approval Date: Feb 25, 1998
Applicant Holder Full Name: CHEPLAPHARM ARZNEIMITTEL GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information

DROXIA (HYDROXYUREA)
400MG
Marketing Status: Prescription

Active Ingredient: HYDROXYUREA
Proprietary Name: DROXIA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 400MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N016295
Product Number: 004
Approval Date: Feb 25, 1998
Applicant Holder Full Name: CHEPLAPHARM ARZNEIMITTEL GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information

HYDREA (HYDROXYUREA)
500MG
Marketing Status: Prescription

Active Ingredient: HYDROXYUREA
Proprietary Name: HYDREA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N016295
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: CHEPLAPHARM ARZNEIMITTEL GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information