Details for New Drug Application (NDA): 211724
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NDA 211724 describes CAPECITABINE, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Hikma, MSN, Reliance Life, Rising, Shilpa, Sun Pharm, Teva Pharms Usa, and Teyro Labs, and is included in fourteen NDAs. It is available from twenty-one suppliers. Additional details are available on the CAPECITABINE profile page.
The generic ingredient in CAPECITABINE is capecitabine. There are twenty-eight drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the capecitabine profile page.
The generic ingredient in CAPECITABINE is capecitabine. There are twenty-eight drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the capecitabine profile page.
Summary for 211724
| Tradename: | CAPECITABINE |
| Applicant: | Reliance Life |
| Ingredient: | capecitabine |
| Patents: | 0 |
Pharmacology for NDA: 211724
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 211724
Suppliers and Packaging for NDA: 211724
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAPECITABINE | capecitabine | TABLET;ORAL | 211724 | ANDA | Chartwell RX, LLC | 62135-783 | 62135-783-60 | 60 TABLET in 1 BOTTLE (62135-783-60) |
| CAPECITABINE | capecitabine | TABLET;ORAL | 211724 | ANDA | Chartwell RX, LLC | 62135-784 | 62135-784-12 | 120 TABLET in 1 BOTTLE (62135-784-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Apr 27, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Apr 27, 2020 | TE: | AB | RLD: | No | ||||
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