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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. It is available from one supplier. There are two patents 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. Forty-five suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.

Summary for NDA: 202088

Tradename:
SUPRENZA
Applicant:
Citius Pharms
Ingredient:
phentermine hydrochloride
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 202088

Suppliers and Packaging for NDA: 202088

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUPRENZA
phentermine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL 202088 NDA Akrimax Pharmaceuticals, LLC 24090-720 24090-720-77 7 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (24090-720-77)
SUPRENZA
phentermine hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL 202088 NDA Akrimax Pharmaceuticals, LLC 24090-720 24090-720-85 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (24090-720-85)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength15MG
Approval Date:Jun 13, 2011TE:RLD:No
Patent:6,149,938Patent Expiration:Jul 23, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:8,440,170Patent Expiration:Mar 14, 2029Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength30MG
Approval Date:Jun 13, 2011TE:RLD:No
Patent:6,149,938Patent Expiration:Jul 23, 2018Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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