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Details for New Drug Application (NDA): 208552
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The generic ingredient in RHOFADE is oxymetazoline hydrochloride. There are three drug master file entries for this compound. One supplier is 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: | 7 |
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: | |||||||||
Patent: | Start Trial | Patent Expiration: | Jun 11, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
Patent: | Start Trial | Patent Expiration: | Jun 11, 2035 | Product Flag? | Substance Flag? | Delist Request? |
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