Product Details for ANDA 076037
NEFAZODONE HYDROCHLORIDE (NEFAZODONE HYDROCHLORIDE)
50MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
150MG
Marketing Status: Prescription
200MG
Marketing Status: Prescription
250MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
Active Ingredient: NEFAZODONE HYDROCHLORIDE
Proprietary Name: NEFAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076037
Product Number: 001
Approval Date: Sep 16, 2003
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
NEFAZODONE HYDROCHLORIDE (NEFAZODONE HYDROCHLORIDE)
Proprietary Name: NEFAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076037
Product Number: 001
Approval Date: Sep 16, 2003
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Prescription
Active Ingredient: NEFAZODONE HYDROCHLORIDE
Proprietary Name: NEFAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076037
Product Number: 002
Approval Date: Sep 16, 2003
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
NEFAZODONE HYDROCHLORIDE (NEFAZODONE HYDROCHLORIDE)
Proprietary Name: NEFAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076037
Product Number: 002
Approval Date: Sep 16, 2003
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
150MG
Marketing Status: Prescription
Active Ingredient: NEFAZODONE HYDROCHLORIDE
Proprietary Name: NEFAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076037
Product Number: 003
Approval Date: Sep 16, 2003
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
NEFAZODONE HYDROCHLORIDE (NEFAZODONE HYDROCHLORIDE)
Proprietary Name: NEFAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076037
Product Number: 003
Approval Date: Sep 16, 2003
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
200MG
Marketing Status: Prescription
Active Ingredient: NEFAZODONE HYDROCHLORIDE
Proprietary Name: NEFAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076037
Product Number: 004
Approval Date: Sep 16, 2003
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
NEFAZODONE HYDROCHLORIDE (NEFAZODONE HYDROCHLORIDE)
Proprietary Name: NEFAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A076037
Product Number: 004
Approval Date: Sep 16, 2003
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
250MG
Marketing Status: Prescription
Active Ingredient: NEFAZODONE HYDROCHLORIDE
Proprietary Name: NEFAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code:
Application Number: A076037
Product Number: 005
Approval Date: Sep 16, 2003
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: NEFAZODONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code:
Application Number: A076037
Product Number: 005
Approval Date: Sep 16, 2003
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information