Details for New Drug Application (NDA): 212520
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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
Physiological Effect | Increased Sympathetic Activity Vasoconstriction |
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: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.1% | ||||
Approval Date: | Jul 8, 2020 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 16, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING BLEPHAROPTOSIS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? |
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