Details for New Drug Application (NDA): 075860
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NDA 075860 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 075860
| Tradename: | DESONIDE |
| Applicant: | Fougera Pharms |
| Ingredient: | desonide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075860
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 075860
Suppliers and Packaging for NDA: 075860
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESONIDE | desonide | LOTION;TOPICAL | 075860 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0310 | 0168-0310-02 | 1 BOTTLE in 1 CARTON (0168-0310-02) / 59 mL in 1 BOTTLE |
| DESONIDE | desonide | LOTION;TOPICAL | 075860 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0310 | 0168-0310-04 | 1 BOTTLE in 1 CARTON (0168-0310-04) / 118 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Mar 19, 2002 | TE: | AB | RLD: | No | ||||
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