Details for New Drug Application (NDA): 210998
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NDA 210998 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.
Summary for 210998
| Tradename: | DESONIDE |
| Applicant: | Encube Ethicals |
| Ingredient: | desonide |
| Patents: | 0 |
Pharmacology for NDA: 210998
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210998
Suppliers and Packaging for NDA: 210998
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESONIDE | desonide | OINTMENT;TOPICAL | 210998 | ANDA | Encube Ethicals Private Limited | 21922-004 | 21922-004-04 | 1 TUBE in 1 CARTON (21922-004-04) / 15 g in 1 TUBE |
| DESONIDE | desonide | OINTMENT;TOPICAL | 210998 | ANDA | Encube Ethicals Private Limited | 21922-004 | 21922-004-07 | 1 TUBE in 1 CARTON (21922-004-07) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Jan 30, 2019 | TE: | AB | RLD: | No | ||||
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