Details for New Drug Application (NDA): 208390
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NDA 208390 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, MSN, Mylan, Prinston Inc, Sciegen Pharms Inc, Sunshine, Taro, and Watson Labs Inc, and is included in seventeen NDAs. It is available from twenty-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. Twenty-five 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-five suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.
Summary for 208390
| Tradename: | TICAGRELOR |
| Applicant: | Watson Labs Inc |
| Ingredient: | ticagrelor |
| Patents: | 0 |
Pharmacology for NDA: 208390
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 208390
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TICAGRELOR | ticagrelor | TABLET;ORAL | 208390 | ANDA | Teva Pharmaceuticals, Inc. | 0480-2688 | 0480-2688-06 | 60 TABLET, FILM COATED in 1 BOTTLE (0480-2688-06) |
| TICAGRELOR | ticagrelor | TABLET;ORAL | 208390 | ANDA | Teva Pharmaceuticals, Inc. | 0480-2695 | 0480-2695-06 | 60 TABLET, FILM COATED in 1 BOTTLE (0480-2695-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Sep 4, 2018 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Oct 28, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
| Approval Date: | Sep 4, 2018 | TE: | AB | RLD: | No | ||||
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