Product Details for ANDA 076665
FLUCONAZOLE (FLUCONAZOLE)
50MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
150MG
Marketing Status: Prescription
200MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
Active Ingredient: FLUCONAZOLE
Proprietary Name: FLUCONAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076665
Product Number: 001
Approval Date: Jul 29, 2004
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
FLUCONAZOLE (FLUCONAZOLE)
Proprietary Name: FLUCONAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076665
Product Number: 001
Approval Date: Jul 29, 2004
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Prescription
Active Ingredient: FLUCONAZOLE
Proprietary Name: FLUCONAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076665
Product Number: 002
Approval Date: Jul 29, 2004
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
FLUCONAZOLE (FLUCONAZOLE)
Proprietary Name: FLUCONAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076665
Product Number: 002
Approval Date: Jul 29, 2004
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
150MG
Marketing Status: Prescription
Active Ingredient: FLUCONAZOLE
Proprietary Name: FLUCONAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076665
Product Number: 003
Approval Date: Jul 29, 2004
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
FLUCONAZOLE (FLUCONAZOLE)
Proprietary Name: FLUCONAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076665
Product Number: 003
Approval Date: Jul 29, 2004
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
200MG
Marketing Status: Prescription
Active Ingredient: FLUCONAZOLE
Proprietary Name: FLUCONAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076665
Product Number: 004
Approval Date: Jul 29, 2004
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: FLUCONAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076665
Product Number: 004
Approval Date: Jul 29, 2004
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status: Prescription
Patent and Exclusivity Information