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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 212520


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NDA 212520 describes UPNEEQ, which is a drug marketed by Rvl Pharms and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the UPNEEQ profile page.

The generic ingredient in UPNEEQ is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.
Summary for 212520
Tradename:UPNEEQ
Applicant:Rvl Pharms
Ingredient:oxymetazoline hydrochloride
Patents:12
Pharmacology for NDA: 212520
Medical Subject Heading (MeSH) Categories for 212520
Suppliers and Packaging for NDA: 212520
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
UPNEEQ oxymetazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 212520 NDA RVL Pharmaceuticals, Inc. 73687-062 73687-062-25 15 AMPULE in 1 CARTON (73687-062-25) / .3 mL in 1 AMPULE (73687-062-80)
UPNEEQ oxymetazoline hydrochloride SOLUTION/DROPS;OPHTHALMIC 212520 NDA RVL Pharmaceuticals, Inc. 73687-062 73687-062-32 30 AMPULE in 1 CARTON (73687-062-32) / .3 mL in 1 AMPULE (73687-062-70)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Jul 8, 2020TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Dec 16, 2039Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING BLEPHAROPTOSIS
Patent:⤷  Sign UpPatent Expiration:Dec 16, 2039Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Dec 16, 2039Product Flag?YSubstance Flag?Delist Request?

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