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Details for New Drug Application (NDA): 208079

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NDA 208079 describes SERNIVO, which is a drug marketed by Promius Pharma Llc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the SERNIVO profile page.

The generic ingredient in SERNIVO is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.

Summary for NDA: 208079

Tradename:
SERNIVO
Applicant:
Promius Pharma Llc
Ingredient:
betamethasone dipropionate
Patents:3
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 208079

Suppliers and Packaging for NDA: 208079

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SERNIVO
betamethasone dipropionate
SPRAY;TOPICAL 208079 NDA Promius Pharma, LLC 67857-808 67857-808-04 1 BOTTLE in 1 CARTON (67857-808-04) > 120 g in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;TOPICALStrengthEQ 0.05% BASE/SPRAY
Approval Date:Feb 5, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 5, 2019
Regulatory Exclusivity Use:NEW DOSAGE FORM
Patent:9,364,485Patent Expiration:Aug 31, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PLAQUE PSORIASIS
Patent:9,433,630Patent Expiration:Aug 31, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PLAQUE PSORIASIS


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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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