Details for New Drug Application (NDA): 213584
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NDA 213584 describes OXYMETAZOLINE HYDROCHLORIDE, which is a drug marketed by Sun Pharma Canada and is included in one NDA. It is available from one supplier. Additional details are available on the OXYMETAZOLINE HYDROCHLORIDE profile page.
The generic ingredient in OXYMETAZOLINE HYDROCHLORIDE is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.
The generic ingredient in OXYMETAZOLINE HYDROCHLORIDE is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.
Summary for 213584
| Tradename: | OXYMETAZOLINE HYDROCHLORIDE |
| Applicant: | Sun Pharma Canada |
| Ingredient: | oxymetazoline hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 213584
| Physiological Effect | Increased Sympathetic Activity Vasoconstriction |
Medical Subject Heading (MeSH) Categories for 213584
Suppliers and Packaging for NDA: 213584
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXYMETAZOLINE HYDROCHLORIDE | oxymetazoline hydrochloride | CREAM;TOPICAL | 213584 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-1405 | 51672-1405-2 | 1 TUBE in 1 CARTON (51672-1405-2) / 30 g in 1 TUBE |
| OXYMETAZOLINE HYDROCHLORIDE | oxymetazoline hydrochloride | CREAM;TOPICAL | 213584 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-1405 | 51672-1405-3 | 1 TUBE in 1 CARTON (51672-1405-3) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Oct 4, 2021 | TE: | AB | RLD: | No | ||||
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