Details for New Drug Application (NDA): 091161
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NDA 091161 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 091161
| Tradename: | MOMETASONE FUROATE |
| Applicant: | Apotex |
| Ingredient: | mometasone furoate |
| Patents: | 0 |
Pharmacology for NDA: 091161
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 091161
Suppliers and Packaging for NDA: 091161
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MOMETASONE FUROATE | mometasone furoate | SPRAY, METERED;NASAL | 091161 | ANDA | Golden State Medical Supply, Inc. | 60429-664 | 60429-664-17 | 1 BOTTLE, PUMP in 1 CARTON (60429-664-17) / 120 SPRAY, METERED in 1 BOTTLE, PUMP |
| MOMETASONE FUROATE | mometasone furoate | SPRAY, METERED;NASAL | 091161 | ANDA | Apotex Corp. | 60505-0830 | 60505-0830-1 | 1 BOTTLE, PUMP in 1 CARTON (60505-0830-1) / 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: | Mar 22, 2016 | TE: | AB | RLD: | No | ||||
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