Details for New Drug Application (NDA): 020896
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The generic ingredient in XELODA 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 020896
| Tradename: | XELODA |
| Applicant: | Cheplapharm |
| Ingredient: | capecitabine |
| Patents: | 0 |
Pharmacology for NDA: 020896
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 020896
Suppliers and Packaging for NDA: 020896
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XELODA | capecitabine | TABLET;ORAL | 020896 | NDA | H2-Pharma, LLC | 61269-475 | 61269-475-12 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-475-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Apr 30, 1998 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Apr 30, 1998 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020896
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cheplapharm | XELODA | capecitabine | TABLET;ORAL | 020896-001 | Apr 30, 1998 | 4,966,891 | ⤷ Start Trial |
| Cheplapharm | XELODA | capecitabine | TABLET;ORAL | 020896-001 | Apr 30, 1998 | 5,472,949*PED | ⤷ Start Trial |
| Cheplapharm | XELODA | capecitabine | TABLET;ORAL | 020896-002 | Apr 30, 1998 | 5,472,949*PED | ⤷ Start Trial |
| Cheplapharm | XELODA | capecitabine | TABLET;ORAL | 020896-002 | Apr 30, 1998 | 4,966,891 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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