Details for New Drug Application (NDA): 214396
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NDA 214396 describes DESONIDE, which is a drug marketed by Alembic, Cadila, Cosette, Glenmark Speclt, 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 fourteen 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. Eighteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the desonide profile page.
Pharmacology for NDA: 214396
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 214396
Suppliers and Packaging for NDA: 214396
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESONIDE | desonide | CREAM;TOPICAL | 214396 | ANDA | Alembic Pharmaceuticals Inc. | 62332-632 | 62332-632-15 | 1 TUBE in 1 CARTON (62332-632-15) / 15 g in 1 TUBE |
| DESONIDE | desonide | CREAM;TOPICAL | 214396 | ANDA | Alembic Pharmaceuticals Inc. | 62332-632 | 62332-632-60 | 1 TUBE in 1 CARTON (62332-632-60) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Dec 8, 2022 | TE: | AB | RLD: | No | ||||
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