Details for New Drug Application (NDA): 208508
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NDA 208508 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 four 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. Seven 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. Seven suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.
Summary for 208508
| Tradename: | TICAGRELOR |
| Applicant: | Sunshine |
| Ingredient: | ticagrelor |
| Patents: | 0 |
Pharmacology for NDA: 208508
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 208508
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TICAGRELOR | ticagrelor | TABLET;ORAL | 208508 | ANDA | Oryza Pharmaceuticals, Inc. | 72516-018 | 72516-018-06 | 60 TABLET in 1 BOTTLE (72516-018-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
| Approval Date: | Apr 6, 2020 | TE: | RLD: | No | |||||
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