Product Details for NDA 202088
SUPRENZA (PHENTERMINE HYDROCHLORIDE)
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PHENTERMINE HYDROCHLORIDE
Proprietary Name: SUPRENZA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N202088
Product Number: 001
Approval Date: Jun 13, 2011
Applicant Holder Full Name: CITIUS PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
SUPRENZA (PHENTERMINE HYDROCHLORIDE)
Proprietary Name: SUPRENZA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N202088
Product Number: 001
Approval Date: Jun 13, 2011
Applicant Holder Full Name: CITIUS PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PHENTERMINE HYDROCHLORIDE
Proprietary Name: SUPRENZA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N202088
Product Number: 002
Approval Date: Jun 13, 2011
Applicant Holder Full Name: CITIUS PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
SUPRENZA (PHENTERMINE HYDROCHLORIDE)
Proprietary Name: SUPRENZA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N202088
Product Number: 002
Approval Date: Jun 13, 2011
Applicant Holder Full Name: CITIUS PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PHENTERMINE HYDROCHLORIDE
Proprietary Name: SUPRENZA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N202088
Product Number: 003
Approval Date: Mar 27, 2012
Applicant Holder Full Name: CITIUS PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: SUPRENZA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N202088
Product Number: 003
Approval Date: Mar 27, 2012
Applicant Holder Full Name: CITIUS PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information