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 |
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: | ⤷ Start Trial | Patent Expiration: | Dec 16, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING BLEPHAROPTOSIS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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