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Details for New Drug Application (NDA): 019625
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NDA 019625 describes ELOCON, which is a drug marketed by Merck Sharp Dohme and is included in three NDAs. It is available from one supplier. Additional details are available on the ELOCON profile page.
The generic ingredient in ELOCON 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 ELOCON 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 019625
| Tradename: | ELOCON |
| Applicant: | Merck Sharp Dohme |
| Ingredient: | mometasone furoate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019625
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 019625
Suppliers and Packaging for NDA: 019625
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELOCON | mometasone furoate | CREAM;TOPICAL | 019625 | NDA | Merck Sharp & Dohme Corp. | 0085-3149 | 0085-3149-01 | 1 TUBE in 1 CARTON (0085-3149-01) > 15 g in 1 TUBE |
| ELOCON | mometasone furoate | CREAM;TOPICAL | 019625 | NDA | Merck Sharp & Dohme Corp. | 0085-3149 | 0085-3149-02 | 1 TUBE in 1 CARTON (0085-3149-02) > 5 g in 1 TUBE |
Paragraph IV (Patent) Challenges for 019625
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ELOCON | CREAM;TOPICAL | mometasone furoate | 019625 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | May 6, 1987 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Apr 19, 2013 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 019625
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | ELOCON | mometasone furoate | CREAM;TOPICAL | 019625-001 | May 6, 1987 | Start Trial | Start Trial |
| Merck Sharp Dohme | ELOCON | mometasone furoate | CREAM;TOPICAL | 019625-001 | May 6, 1987 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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