Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022580

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QSYMIA (PHENTERMINE HYDROCHLORIDE; TOPIRAMATE)
EQ 3.75MG BASE;23MG
Marketing Status: Prescription
Active Ingredient: PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Proprietary Name: QSYMIA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 3.75MG BASE;23MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022580
Product Number: 001
Approval Date: Jul 17, 2012
Applicant Holder Full Name: VIVUS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
QSYMIA (PHENTERMINE HYDROCHLORIDE; TOPIRAMATE)
EQ 7.5MG BASE;46MG
Marketing Status: Prescription
Active Ingredient: PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Proprietary Name: QSYMIA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 7.5MG BASE;46MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022580
Product Number: 002
Approval Date: Jul 17, 2012
Applicant Holder Full Name: VIVUS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
QSYMIA (PHENTERMINE HYDROCHLORIDE; TOPIRAMATE)
EQ 11.25MG BASE;69MG
Marketing Status: Prescription
Active Ingredient: PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Proprietary Name: QSYMIA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 11.25MG BASE;69MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022580
Product Number: 003
Approval Date: Jul 17, 2012
Applicant Holder Full Name: VIVUS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
QSYMIA (PHENTERMINE HYDROCHLORIDE; TOPIRAMATE)
EQ 15MG BASE;92MG
Marketing Status: Prescription
Active Ingredient: PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Proprietary Name: QSYMIA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 15MG BASE;92MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022580
Product Number: 004
Approval Date: Jul 17, 2012
Applicant Holder Full Name: VIVUS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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