Details for New Drug Application (NDA): 209996
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The generic ingredient in DESONIDE is desonide. There are thirty-one drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the desonide profile page.
Summary for 209996
Tradename: | DESONIDE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | desonide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209996
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 209996
Suppliers and Packaging for NDA: 209996
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DESONIDE | desonide | OINTMENT;TOPICAL | 209996 | ANDA | Northstar Rx LLC | 16714-828 | 16714-828-01 | 1 TUBE in 1 CARTON (16714-828-01) / 15 g in 1 TUBE |
DESONIDE | desonide | OINTMENT;TOPICAL | 209996 | ANDA | Northstar Rx LLC | 16714-828 | 16714-828-02 | 1 TUBE in 1 CARTON (16714-828-02) / 60 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Sep 15, 2017 | TE: | AB | RLD: | No |
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