Details for New Drug Application (NDA): 077770
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NDA 077770 describes DESOXIMETASONE, which is a drug marketed by Actavis Mid Atlantic, Cosette, Fougera Pharms, Lupin, Padagis Israel, Rising, Sciegen Pharms Inc, Zydus Lifesciences, Epic Pharma Llc, Padagis Us, Altana, Glenmark Pharms Ltd, Novel Labs Inc, Pai Holdings Pharm, and The J Molner, and is included in thirty NDAs. It is available from eleven 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the desoximetasone profile page.
Summary for 077770
| Tradename: | DESOXIMETASONE |
| Applicant: | Padagis Israel |
| Ingredient: | desoximetasone |
| Patents: | 0 |
Pharmacology for NDA: 077770
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 077770
Suppliers and Packaging for NDA: 077770
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESOXIMETASONE | desoximetasone | OINTMENT;TOPICAL | 077770 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-496 | 45802-496-14 | 1 TUBE in 1 CARTON (45802-496-14) / 15 g in 1 TUBE |
| DESOXIMETASONE | desoximetasone | OINTMENT;TOPICAL | 077770 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-496 | 45802-496-96 | 1 TUBE in 1 CARTON (45802-496-96) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.25% | ||||
| Approval Date: | Apr 20, 2015 | TE: | AB | RLD: | No | ||||
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