Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 074582

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DANAZOL (DANAZOL)
50MG
Marketing Status: Prescription

Active Ingredient: DANAZOL
Proprietary Name: DANAZOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074582
Product Number: 003
Approval Date: May 29, 1998
Applicant Holder Full Name: BARR LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DANAZOL (DANAZOL)
100MG
Marketing Status: Prescription

Active Ingredient: DANAZOL
Proprietary Name: DANAZOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074582
Product Number: 002
Approval Date: May 29, 1998
Applicant Holder Full Name: BARR LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DANAZOL (DANAZOL)
200MG
Marketing Status: Prescription

Active Ingredient: DANAZOL
Proprietary Name: DANAZOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A074582
Product Number: 001
Approval Date: Aug 9, 1996
Applicant Holder Full Name: BARR LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information