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Details for New Drug Application (NDA): 208552
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NDA 208552 describes RHOFADE, which is a drug marketed by Epi Hlth and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the RHOFADE profile page.
The generic ingredient in RHOFADE is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.
The generic ingredient in RHOFADE is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.
Summary for 208552
| Tradename: | RHOFADE |
| Applicant: | Epi Hlth |
| Ingredient: | oxymetazoline hydrochloride |
| Patents: | 6 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208552
| Physiological Effect | Vasoconstriction Increased Sympathetic Activity |
Medical Subject Heading (MeSH) Categories for 208552
Suppliers and Packaging for NDA: 208552
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552 | NDA | Allergan, Inc. | 0023-5300 | 0023-5300-30 | 1 TUBE in 1 CARTON (0023-5300-30) > 30 g in 1 TUBE |
| RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552 | NDA | Allergan, Inc. | 0023-5300 | 0023-5300-35 | 1 BOTTLE, PUMP in 1 CARTON (0023-5300-35) > 30 g in 1 BOTTLE, PUMP |
Paragraph IV (Patent) Challenges for 208552
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| RHOFADE | CREAM;TOPICAL | oxymetazoline hydrochloride | 208552 | 2019-06-20 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Jan 18, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 18, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jun 11, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM, WHERE THE PATIENT EXPERIENCES NO REBOUND OR WORSENING OF FACIAL ERYTHEMA POST-TREATMENT | ||||||||
| Patent: | Start Trial | Patent Expiration: | May 2, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM | ||||||||
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