Details for New Drug Application (NDA): 208599
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NDA 208599 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 Ltd, Mankind Pharma, MSN, Mylan, Prinston Inc, Sciegen Pharms, Sunshine, Taro, and Watson Labs Inc, and is included in eighteen NDAs. It is available from twenty-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. Twenty-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. Twenty-six suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.
Summary for 208599
| Tradename: | TICAGRELOR |
| Applicant: | Prinston Inc |
| Ingredient: | ticagrelor |
| Patents: | 0 |
Pharmacology for NDA: 208599
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 208599
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TICAGRELOR | ticagrelor | TABLET;ORAL | 208599 | ANDA | Solco Healthcare U.S., LLC | 43547-657 | 43547-657-06 | 60 TABLET, FILM COATED in 1 BOTTLE (43547-657-06) |
| TICAGRELOR | ticagrelor | TABLET;ORAL | 208599 | ANDA | Solco Healthcare U.S., LLC | 43547-657 | 43547-657-18 | 180 TABLET, FILM COATED in 1 BOTTLE (43547-657-18) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
| Approval Date: | Aug 16, 2024 | TE: | AB | RLD: | No | ||||
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