Details for New Drug Application (NDA): 208575
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NDA 208575 describes TICAGRELOR, which is a drug marketed by Alkem Labs Ltd, Amneal, Dr Reddys, Hisun Pharm Hangzhou, MSN, Mylan, Prinston Inc, Sunshine, and Watson Labs Inc, and is included in nine NDAs. It is available from three suppliers. Additional details are available on the TICAGRELOR profile page.
The generic ingredient in TICAGRELOR is ticagrelor. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.
The generic ingredient in TICAGRELOR is ticagrelor. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.
Summary for 208575
| Tradename: | TICAGRELOR |
| Applicant: | Hisun Pharm Hangzhou |
| Ingredient: | ticagrelor |
| Patents: | 0 |
Pharmacology for NDA: 208575
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 208575
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TICAGRELOR | ticagrelor | TABLET;ORAL | 208575 | ANDA | Hisun Pharmaceuticals USA, Inc. | 42658-115 | 42658-115-03 | 60 TABLET, FILM COATED in 1 BOTTLE (42658-115-03) |
| TICAGRELOR | ticagrelor | TABLET;ORAL | 208575 | ANDA | Hisun Pharmaceuticals USA, Inc. | 42658-115 | 42658-115-07 | 500 TABLET, FILM COATED in 1 BOTTLE (42658-115-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
| Approval Date: | Jan 23, 2019 | TE: | AB | RLD: | No | ||||
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