Details for New Drug Application (NDA): 217237
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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 217237
Tradename: | CAPECITABINE |
Applicant: | Teyro Labs |
Ingredient: | capecitabine |
Patents: | 0 |
Pharmacology for NDA: 217237
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 217237
Suppliers and Packaging for NDA: 217237
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CAPECITABINE | capecitabine | TABLET;ORAL | 217237 | ANDA | Teyro Labs Private Limited | 82511-001 | 82511-001-15 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82511-001-15) |
CAPECITABINE | capecitabine | TABLET;ORAL | 217237 | ANDA | Teyro Labs Private Limited | 82511-002 | 82511-002-50 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82511-002-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Oct 23, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Oct 23, 2023 | TE: | AB | RLD: | No |
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