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Details for New Drug Application (NDA): 204820
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NDA 204820 describes MITIGARE, which is a drug marketed by Hikma Intl Pharms and is included in one NDA. It is available from four suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MITIGARE profile page.
The generic ingredient in MITIGARE is colchicine. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the colchicine profile page.
The generic ingredient in MITIGARE is colchicine. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the colchicine profile page.
Summary for 204820
| Tradename: | MITIGARE |
| Applicant: | Hikma Intl Pharms |
| Ingredient: | colchicine |
| Patents: | 5 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204820
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for 204820
Suppliers and Packaging for NDA: 204820
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MITIGARE | colchicine | CAPSULE;ORAL | 204820 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-3018 | 0143-3018-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-01) |
| MITIGARE | colchicine | CAPSULE;ORAL | 204820 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-3018 | 0143-3018-10 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-10) |
Paragraph IV (Patent) Challenges for 204820
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MITIGARE | CAPSULE;ORAL | colchicine | 204820 | 2016-06-10 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.6MG | ||||
| Approval Date: | Sep 26, 2014 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Aug 22, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES | ||||||||
| Patent: | Start Trial | Patent Expiration: | Aug 22, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES | ||||||||
| Patent: | Start Trial | Patent Expiration: | Aug 22, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES | ||||||||
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