Details for New Drug Application (NDA): 209365
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NDA 209365 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, Reliance Life, Rising, Shilpa, Sun Pharm, Teva Pharms Usa, and Teyro Labs, and is included in fourteen NDAs. It is available from twenty-two suppliers. Additional details are available on the CAPECITABINE profile page.
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.
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 209365
| Tradename: | CAPECITABINE |
| Applicant: | Msn |
| Ingredient: | capecitabine |
| Patents: | 0 |
Pharmacology for NDA: 209365
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 209365
Suppliers and Packaging for NDA: 209365
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAPECITABINE | capecitabine | TABLET;ORAL | 209365 | ANDA | Cipla USA Inc. | 69097-948 | 69097-948-08 | 120 TABLET, FILM COATED in 1 BOTTLE (69097-948-08) |
| CAPECITABINE | capecitabine | TABLET;ORAL | 209365 | ANDA | Cipla USA Inc. | 69097-949 | 69097-949-03 | 60 TABLET, FILM COATED in 1 BOTTLE (69097-949-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Jul 2, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Jul 2, 2018 | TE: | AB | RLD: | No | ||||
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