Details for New Drug Application (NDA): 206441
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NDA 206441 describes DESOXIMETASONE, which is a drug marketed by Actavis Mid Atlantic, Cosette, Fougera Pharms, Lupin, Padagis Israel, Rising, Saptalis Pharms, Zydus Lifesciences, Epic Pharma Llc, Padagis Us, Altana, Glenmark Generics, Novel Labs Inc, Pai Holdings Pharm, and The J Molner, and is included in thirty NDAs. It is available from twelve suppliers. Additional details are available on the DESOXIMETASONE profile page.
The generic ingredient in DESOXIMETASONE is desoximetasone. There are seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the desoximetasone profile page.
The generic ingredient in DESOXIMETASONE is desoximetasone. There are seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the desoximetasone profile page.
Summary for 206441
| Tradename: | DESOXIMETASONE |
| Applicant: | Padagis Israel |
| Ingredient: | desoximetasone |
| Patents: | 0 |
Pharmacology for NDA: 206441
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 206441
Suppliers and Packaging for NDA: 206441
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESOXIMETASONE | desoximetasone | SPRAY;TOPICAL | 206441 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-807 | 45802-807-98 | 1 BOTTLE, SPRAY in 1 CARTON (45802-807-98) / 100 mL in 1 BOTTLE, SPRAY |
| DESOXIMETASONE | desoximetasone | SPRAY;TOPICAL | 206441 | ANDA | Bryant Ranch Prepack | 63629-8702 | 63629-8702-1 | 1 BOTTLE, SPRAY in 1 CARTON (63629-8702-1) / 100 mL in 1 BOTTLE, SPRAY |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;TOPICAL | Strength | 0.25% | ||||
| Approval Date: | Jan 20, 2017 | TE: | AT | RLD: | No | ||||
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