Details for New Drug Application (NDA): 208537
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NDA 208537 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 208537
| Tradename: | TICAGRELOR |
| Applicant: | Invagen Pharms |
| Ingredient: | ticagrelor |
| Patents: | 0 |
Pharmacology for NDA: 208537
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 208537
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TICAGRELOR | ticagrelor | TABLET;ORAL | 208537 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 71610-914 | 71610-914-41 | 5400 TABLET, FILM COATED in 1 BOTTLE (71610-914-41) |
| TICAGRELOR | ticagrelor | TABLET;ORAL | 208537 | ANDA | Exelan Pharmaceuticals, Inc | 76282-550 | 76282-550-01 | 100 TABLET, FILM COATED in 1 BOTTLE (76282-550-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
| Approval Date: | May 5, 2025 | 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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