Details for New Drug Application (NDA): 200483
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NDA 200483 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 200483
| Tradename: | CAPECITABINE |
| Applicant: | Hikma |
| Ingredient: | capecitabine |
| Patents: | 0 |
Pharmacology for NDA: 200483
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 200483
Suppliers and Packaging for NDA: 200483
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAPECITABINE | capecitabine | TABLET;ORAL | 200483 | ANDA | Golden State Medical Supply, Inc. | 51407-095 | 51407-095-60 | 60 TABLET, FILM COATED in 1 BOTTLE (51407-095-60) |
| CAPECITABINE | capecitabine | TABLET;ORAL | 200483 | ANDA | Golden State Medical Supply, Inc. | 51407-096 | 51407-096-12 | 120 TABLET, FILM COATED in 1 BOTTLE (51407-096-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Jul 14, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Jul 14, 2016 | TE: | AB | RLD: | No | ||||
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