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Last Updated: February 29, 2024

Details for New Drug Application (NDA): 208079


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NDA 208079 describes SERNIVO, which is a drug marketed by Primus Pharms and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. 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-five suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.
Summary for 208079
Tradename:SERNIVO
Applicant:Primus Pharms
Ingredient:betamethasone dipropionate
Patents:7
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 Primus Pharmaceuticals, Inc. 68040-714 68040-714-08 1 BOTTLE, SPRAY in 1 CARTON (68040-714-08) / 10 g in 1 BOTTLE, SPRAY
SERNIVO betamethasone dipropionate SPRAY;TOPICAL 208079 NDA Primus Pharmaceuticals, Inc. 68040-714 68040-714-28 1 BOTTLE, SPRAY in 1 CARTON (68040-714-28) / 120 g in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;TOPICALStrengthEQ 0.05% BASE/SPRAY
Approval Date:Feb 5, 2016TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Aug 31, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PLAQUE PSORIASIS
Patent:⤷  Try a TrialPatent Expiration:Aug 31, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PLAQUE PSORIASIS
Patent:⤷  Try a TrialPatent Expiration:Aug 31, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PLAQUE PSORIASIS

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