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. Three suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.
The generic ingredient in UPNEEQ is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Three 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212520
Generic Entry Date for 212520*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION/DROPS;OPHTHALMIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 | 73687-062-32 | 30 AMPULE in 1 CARTON (73687-062-32) / .3 mL in 1 AMPULE (73687-062-70) |
| UPNEEQ | oxymetazoline hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 212520 | NDA | RVL Pharmaceuticals, Inc. | 73687-062 | 73687-062-68 | 5 AMPULE in 1 CARTON (73687-062-68) / .3 mL in 1 AMPULE (73687-062-80) |
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: | 10,799,481 | Patent Expiration: | Dec 16, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING BLEPHAROPTOSIS | ||||||||
| Patent: | 10,814,001 | Patent Expiration: | Dec 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,898,573 | Patent Expiration: | Dec 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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