Details for New Drug Application (NDA): 204668
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The generic ingredient in CAPECITABINE 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 204668
Tradename: | CAPECITABINE |
Applicant: | Sun Pharm |
Ingredient: | capecitabine |
Patents: | 0 |
Pharmacology for NDA: 204668
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 204668
Suppliers and Packaging for NDA: 204668
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CAPECITABINE | capecitabine | TABLET;ORAL | 204668 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-238 | 62756-238-18 | 1000 TABLET, FILM COATED in 1 BOTTLE (62756-238-18) |
CAPECITABINE | capecitabine | TABLET;ORAL | 204668 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-238 | 62756-238-86 | 60 TABLET, FILM COATED in 1 BOTTLE (62756-238-86) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Jun 21, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jun 21, 2019 | TE: | AB | RLD: | No |
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