Details for New Drug Application (NDA): 211519
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The generic ingredient in COLCHICINE 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 211519
Tradename: | COLCHICINE |
Applicant: | Zydus Pharms |
Ingredient: | colchicine |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 211519
Suppliers and Packaging for NDA: 211519
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
COLCHICINE | colchicine | TABLET;ORAL | 211519 | ANDA | Northstar Rx LLC. | 16714-039 | 16714-039-01 | 1 BOTTLE in 1 CARTON (16714-039-01) / 30 TABLET in 1 BOTTLE |
COLCHICINE | colchicine | TABLET;ORAL | 211519 | ANDA | Northstar Rx LLC. | 16714-039 | 16714-039-02 | 1 BOTTLE in 1 CARTON (16714-039-02) / 100 TABLET in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.6MG | ||||
Approval Date: | Feb 19, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.3MG | ||||
Approval Date: | Nov 14, 2019 | TE: | RLD: | No |
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