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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 two suppliers. There are two patents protecting this drug. Additional details are available on the MITIGARE profile page.

The generic ingredient in MITIGARE is colchicine. There are fifteen drug master file entries for this compound. Ten suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the colchicine profile page.

Summary for NDA: 204820

Tradename:
MITIGARE
Applicant:
Hikma Intl Pharms
Ingredient:
colchicine
Patents:2
Therapeutic Class:Antigout Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 West-Ward Pharmaceuticals Corp 0143-3018 0143-3018-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-01)
MITIGARE
colchicine
CAPSULE;ORAL 204820 NDA West-Ward Pharmaceuticals Corp 0143-3018 0143-3018-10 1000 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.6MG
Approval Date:Sep 26, 2014TE:RLD:Yes
Patent:8,927,607Patent Expiration:Aug 22, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
Patent:9,399,036Patent Expiration:Aug 22, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES


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