Details for New Drug Application (NDA): 207989
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NDA 207989 describes MOMETASONE FUROATE, which is a drug marketed by Anda Repository, Cosette, Fougera Pharms, Glenmark Pharms Inc, Taro, Encube, Glenmark Pharms Ltd, Padagis Israel, Padagis Us, Torrent, Amneal, Amneal Pharms, Apotex, and Aurobindo Pharma, and is included in twenty-three NDAs. It is available from thirteen suppliers. Additional details are available on the MOMETASONE FUROATE profile page.
The generic ingredient in MOMETASONE FUROATE is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
The generic ingredient in MOMETASONE FUROATE is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
Summary for 207989
| Tradename: | MOMETASONE FUROATE |
| Applicant: | Amneal Pharms |
| Ingredient: | mometasone furoate |
| Patents: | 0 |
Pharmacology for NDA: 207989
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 207989
Suppliers and Packaging for NDA: 207989
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MOMETASONE FUROATE | mometasone furoate | SPRAY, METERED;NASAL | 207989 | ANDA | Amneal Pharmaceuticals LLC | 65162-891 | 65162-891-29 | 1 BOTTLE, PUMP in 1 CARTON (65162-891-29) / 120 SPRAY, METERED in 1 BOTTLE, PUMP |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.05MG/SPRAY | ||||
| Approval Date: | Apr 3, 2017 | TE: | AB | RLD: | No | ||||
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