Details for New Drug Application (NDA): 209876
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NDA 209876 describes COLCHICINE, which is a drug marketed by Par Pharm Inc, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Granules, Hetero Labs Ltd V, Mylan, Strides Pharma, Watson Labs Inc, and Zydus Pharms, and is included in twelve NDAs. It is available from twenty-three suppliers. Additional details are available on the COLCHICINE profile page.
The generic ingredient in COLCHICINE is colchicine. There are sixteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the colchicine profile page.
The generic ingredient in COLCHICINE is colchicine. There are sixteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the colchicine profile page.
Summary for 209876
| Tradename: | COLCHICINE |
| Applicant: | Dr Reddys |
| Ingredient: | colchicine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209876
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for 209876
Suppliers and Packaging for NDA: 209876
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COLCHICINE | colchicine | TABLET;ORAL | 209876 | ANDA | Dr.Reddys Laboratories, Inc. | 43598-372 | 43598-372-01 | 100 TABLET in 1 BOTTLE (43598-372-01) |
| COLCHICINE | colchicine | TABLET;ORAL | 209876 | ANDA | Dr.Reddys Laboratories, Inc. | 43598-372 | 43598-372-10 | 1000 TABLET in 1 BOTTLE (43598-372-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.6MG | ||||
| Approval Date: | Sep 6, 2019 | TE: | AB | RLD: | No | ||||
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