Details for New Drug Application (NDA): 202088

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NDA 202088 describes SUPRENZA, which is a drug marketed by Citius Pharms and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the SUPRENZA profile page.

The generic ingredient in SUPRENZA is phentermine hydrochloride. There are seventeen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.

Summary for 202088

Tradename:	SUPRENZA
Applicant:	Citius Pharms
Ingredient:	phentermine hydrochloride
Patents:	1

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 13, 2011	TE:		RLD:	No
Patent:	⤷ Sign Up	Patent Expiration:	Mar 14, 2029	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 13, 2011	TE:		RLD:	No
Patent:	⤷ Sign Up	Patent Expiration:	Mar 14, 2029	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 27, 2012	TE:		RLD:	No
Patent:	⤷ Sign Up	Patent Expiration:	Mar 14, 2029	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 202088

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-001	Jun 13, 2011	⤷ Sign Up	⤷ Sign Up
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-003	Mar 27, 2012	⤷ Sign Up	⤷ Sign Up
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-002	Jun 13, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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