Details for New Drug Application (NDA): 208104
NDA 208104 describes DESOXIMETASONE, which is a drug marketed by Actavis Mid Atlantic, Cosette Pharms Nc, Fougera Pharms, Lupin, Padagis Israel, Rising, Sciegen Pharms, Zydus Lifesciences, Epic Pharma Llc, Padagis Us, Altana, Encube, Glenmark Pharms Ltd, Novel Labs Inc, 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 is one drug master file entry 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 is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the desoximetasone profile page.
Summary for 208104
| Tradename: | DESOXIMETASONE |
| Applicant: | Lupin |
| Ingredient: | desoximetasone |
| Patents: | 0 |
Pharmacology for NDA: 208104
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 208104
Suppliers and Packaging for NDA: 208104
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESOXIMETASONE | desoximetasone | OINTMENT;TOPICAL | 208104 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-946 | 68180-946-01 | 1 TUBE in 1 CARTON (68180-946-01) / 15 g in 1 TUBE |
| DESOXIMETASONE | desoximetasone | OINTMENT;TOPICAL | 208104 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-946 | 68180-946-04 | 1 TUBE in 1 CARTON (68180-946-04) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.25% | ||||
| Approval Date: | Dec 1, 2016 | TE: | AB | RLD: | No | ||||
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