Details for New Drug Application (NDA): 207652
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NDA 207652 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 eighteen suppliers. Additional details are available on the CAPECITABINE profile page.
The generic ingredient in CAPECITABINE is capecitabine. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the capecitabine profile page.
The generic ingredient in CAPECITABINE is capecitabine. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the capecitabine profile page.
Summary for 207652
| Tradename: | CAPECITABINE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | capecitabine |
| Patents: | 0 |
Pharmacology for NDA: 207652
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 207652
Suppliers and Packaging for NDA: 207652
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAPECITABINE | capecitabine | TABLET;ORAL | 207652 | ANDA | Ascend Laboratories, LLC | 67877-458 | 67877-458-12 | 120 TABLET, FILM COATED in 1 BOTTLE (67877-458-12) |
| CAPECITABINE | capecitabine | TABLET;ORAL | 207652 | ANDA | Ascend Laboratories, LLC | 67877-458 | 67877-458-30 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-458-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Nov 24, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Nov 24, 2017 | TE: | AB | RLD: | No | ||||
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