Details for New Drug Application (NDA): 207456
NDA 207456 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, Rising, Shilpa, Somerset Theraps Llc, Sun Pharm, Teva Pharms Usa, and Teyro Labs, and is included in fourteen NDAs. It is available from eighteen suppliers. Additional details are available on the CAPECITABINE profile page.
The generic ingredient in CAPECITABINE is capecitabine. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the capecitabine profile page.
The generic ingredient in CAPECITABINE is capecitabine. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the capecitabine profile page.
Summary for 207456
| Tradename: | CAPECITABINE |
| Applicant: | Shilpa |
| Ingredient: | capecitabine |
| Patents: | 0 |
Pharmacology for NDA: 207456
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 207456
Suppliers and Packaging for NDA: 207456
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAPECITABINE | capecitabine | TABLET;ORAL | 207456 | ANDA | Armas Pharmaceuticals Inc. | 72485-204 | 72485-204-60 | 1 BOTTLE in 1 CARTON (72485-204-60) / 60 TABLET, FILM COATED in 1 BOTTLE |
| CAPECITABINE | capecitabine | TABLET;ORAL | 207456 | ANDA | Armas Pharmaceuticals Inc. | 72485-205 | 72485-205-12 | 1 BOTTLE in 1 CARTON (72485-205-12) / 120 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Dec 12, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Dec 12, 2016 | TE: | AB | RLD: | No | ||||
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