Details for New Drug Application (NDA): 208596
NDA 208596 describes TICAGRELOR, which is a drug marketed by Alembic, Alkem Labs Ltd, Amneal, Apotex, Changzhou Pharm, Dr Reddys, Hisun Pharm Hangzhou, Invagen Pharms, Macleods Pharms, Mankind Pharma, Micro Labs, MSN, Mylan, Pharmobedient, Prinston Inc, Sciegen Pharms, Sunshine, Taro, Watson Labs Inc, and Zhejiang Jingxin, and is included in twenty-one NDAs. It is available from twenty-nine suppliers. Additional details are available on the TICAGRELOR profile page.
The generic ingredient in TICAGRELOR is ticagrelor. There is one drug master file entry for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.
The generic ingredient in TICAGRELOR is ticagrelor. There is one drug master file entry for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.
Summary for 208596
| Tradename: | TICAGRELOR |
| Applicant: | Msn |
| Ingredient: | ticagrelor |
| Patents: | 0 |
Pharmacology for NDA: 208596
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 208596
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TICAGRELOR | ticagrelor | TABLET;ORAL | 208596 | ANDA | AvPAK | 50268-826 | 50268-826-01 | 100 BLISTER PACK in 1 BOX (50268-826-01) / 1 TABLET in 1 BLISTER PACK (50268-826-11) |
| TICAGRELOR | ticagrelor | TABLET;ORAL | 208596 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 53401-028 | 53401-028-42 | 1800 TABLET in 1 BOTTLE (53401-028-42) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
| Approval Date: | Apr 7, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Oct 28, 2025 | TE: | AB | RLD: | No | ||||
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