Details for New Drug Application (NDA): 022352
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NDA 022352 describes COLCRYS, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from seven suppliers. There are seventeen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the COLCRYS profile page.
The generic ingredient in COLCRYS is colchicine. There are sixteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the colchicine profile page.
The generic ingredient in COLCRYS is colchicine. There are sixteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the colchicine profile page.
Summary for 022352
| Tradename: | COLCRYS |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | colchicine |
| Patents: | 17 |
Pharmacology for NDA: 022352
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for 022352
Suppliers and Packaging for NDA: 022352
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLCRYS | colchicine | TABLET;ORAL | 022352 | NDA AUTHORIZED GENERIC | Par Pharmaceutical, Inc. | 0254-2008 | 0254-2008-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0254-2008-01) |
| COLCRYS | colchicine | TABLET;ORAL | 022352 | NDA AUTHORIZED GENERIC | Par Pharmaceutical, Inc. | 0254-2008 | 0254-2008-11 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0254-2008-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.6MG | ||||
| Approval Date: | Jul 29, 2009 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 10, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING GOUT FLARES | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 3, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 17, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES | ||||||||
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