Details for New Drug Application (NDA): 091649
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NDA 091649 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 are twenty-eight drug master file entries 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 are twenty-eight drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the capecitabine profile page.
Summary for 091649
| Tradename: | CAPECITABINE |
| Applicant: | Teva Pharms Usa |
| Ingredient: | capecitabine |
| Patents: | 0 |
Pharmacology for NDA: 091649
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 091649
Suppliers and Packaging for NDA: 091649
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAPECITABINE | capecitabine | TABLET;ORAL | 091649 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7473 | 0093-7473-06 | 60 TABLET, FILM COATED in 1 BOTTLE (0093-7473-06) |
| CAPECITABINE | capecitabine | TABLET;ORAL | 091649 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7474 | 0093-7474-89 | 120 TABLET, FILM COATED in 1 BOTTLE (0093-7474-89) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Sep 16, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Sep 16, 2013 | TE: | AB | RLD: | No | ||||
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