Details for New Drug Application (NDA): 208531
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NDA 208531 describes TICAGRELOR, which is a drug marketed by Alkem Labs Ltd, Amneal, Hisun Pharm Hangzhou, Mylan, Prinston Inc, Sigmapharm Labs Llc, Sunshine, and Watson Labs Inc, and is included in eight NDAs. It is available from one supplier. 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.
Summary for 208531
| Tradename: | TICAGRELOR |
| Applicant: | Amneal |
| Ingredient: | ticagrelor |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208531
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TICAGRELOR | ticagrelor | TABLET;ORAL | 208531 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1134 | 69238-1134-1 | 100 TABLET in 1 BOTTLE (69238-1134-1) |
| TICAGRELOR | ticagrelor | TABLET;ORAL | 208531 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1134 | 69238-1134-6 | 60 TABLET in 1 BOTTLE (69238-1134-6) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
| Approval Date: | Jan 23, 2019 | TE: | RLD: | No | |||||
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