Details for New Drug Application (NDA): 208552
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NDA 208552 describes RHOFADE, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from two suppliers. There are seven 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. Three 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. Three suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.
Summary for 208552
| Tradename: | RHOFADE |
| Applicant: | Mayne Pharma |
| Ingredient: | oxymetazoline hydrochloride |
| Patents: | 7 |
Pharmacology for NDA: 208552
| Physiological Effect | Increased Sympathetic Activity Vasoconstriction |
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 | Mayne Pharma | 51862-765 | 51862-765-00 | 15 TUBE in 1 CARTON (51862-765-00) / 3 g in 1 TUBE |
| RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552 | NDA | Mayne Pharma | 51862-765 | 51862-765-30 | 1 TUBE in 1 CARTON (51862-765-30) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Jan 18, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | 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: | ⤷ Get Started Free | 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 | ||||||||
| Patent: | ⤷ Get Started Free | 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 FEMALE ADULTS | ||||||||
Expired US Patents for NDA 208552
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mayne Pharma | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | ⤷ Get Started Free | ⤷ Get Started Free |
| Mayne Pharma | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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