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Details for New Drug Application (NDA): 020762
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NDA 020762 describes NASONEX, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from two suppliers. Additional details are available on the NASONEX profile page.
The generic ingredient in NASONEX is mometasone furoate. There are thirty drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
The generic ingredient in NASONEX is mometasone furoate. There are thirty drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
Summary for 020762
| Tradename: | NASONEX |
| Applicant: | Merck Sharp Dohme |
| Ingredient: | mometasone furoate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020762
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 020762
Suppliers and Packaging for NDA: 020762
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762 | NDA | Merck Sharp & Dohme Corp. | 0085-1288 | 0085-1288-01 | 1 BOTTLE, PUMP in 1 CARTON (0085-1288-01) > 120 SPRAY, METERED in 1 BOTTLE, PUMP |
| NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762 | NDA | Merck Sharp & Dohme Corp. | 0085-1288 | 0085-1288-03 | 1 BOTTLE, PUMP in 1 CARTON (0085-1288-03) > 28 SPRAY, METERED in 1 BOTTLE, PUMP |
Paragraph IV (Patent) Challenges for 020762
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NASONEX | SPRAY, METERED;NASAL | mometasone furoate | 020762 | 2009-08-07 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.05MG/SPRAY | ||||
| Approval Date: | Oct 1, 1997 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020762
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762-001 | Oct 1, 1997 | Start Trial | Start Trial |
| Merck Sharp Dohme | NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762-001 | Oct 1, 1997 | Start Trial | Start Trial |
| Merck Sharp Dohme | NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762-001 | Oct 1, 1997 | Start Trial | Start Trial |
| Merck Sharp Dohme | NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762-001 | Oct 1, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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