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. Twenty-four 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 | Genentech, Inc. | 0004-1100 | 0004-1100-20 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-1100-20) |
XELODA | capecitabine | TABLET;ORAL | 020896 | NDA | Genentech, Inc. | 0004-1101 | 0004-1101-50 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-1101-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Apr 30, 1998 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Apr 30, 1998 | TE: | AB | 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 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | XELODA | capecitabine | TABLET;ORAL | 020896-002 | Apr 30, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | XELODA | capecitabine | TABLET;ORAL | 020896-002 | Apr 30, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | XELODA | capecitabine | TABLET;ORAL | 020896-001 | Apr 30, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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