Details for New Drug Application (NDA): 073548
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NDA 073548 describes DESONIDE, which is a drug marketed by Alembic, Cadila, Cosette, Glenmark Pharms, Padagis Us, Taro, Cintex Svcs, Fougera Pharms, Pai Holdings Pharm, Encube Ethicals, Glenmark Pharms Ltd, and Hikma, and is included in twenty NDAs. It is available from thirteen suppliers. Additional details are available on the DESONIDE profile page.
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.
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 073548
| Tradename: | DESONIDE |
| Applicant: | Taro |
| Ingredient: | desonide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 073548
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 073548
Suppliers and Packaging for NDA: 073548
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESONIDE | desonide | CREAM;TOPICAL | 073548 | ANDA | NORTHSTAR RX LLC | 16714-729 | 16714-729-01 | 1 TUBE in 1 CARTON (16714-729-01) / 15 g in 1 TUBE |
| DESONIDE | desonide | CREAM;TOPICAL | 073548 | ANDA | NORTHSTAR RX LLC | 16714-729 | 16714-729-02 | 1 TUBE in 1 CARTON (16714-729-02) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Jun 30, 1992 | TE: | AB | RLD: | No | ||||
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