Details for New Drug Application (NDA): 205927
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NDA 205927 describes PRASUGREL, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Hec Pharm, Lupin Ltd, Mylan, Panacea, and Unichem, and is included in ten NDAs. It is available from seven suppliers. Additional details are available on the PRASUGREL profile page.
The generic ingredient in PRASUGREL is prasugrel hydrochloride. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.
The generic ingredient in PRASUGREL is prasugrel hydrochloride. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.
Summary for 205927
| Tradename: | PRASUGREL |
| Applicant: | Mylan |
| Ingredient: | prasugrel hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 205927
| Mechanism of Action | P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Medical Subject Heading (MeSH) Categories for 205927
Suppliers and Packaging for NDA: 205927
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRASUGREL | prasugrel hydrochloride | TABLET;ORAL | 205927 | ANDA | Mylan Pharmaceuticals Inc. | 0378-5185 | 0378-5185-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5185-93) |
| PRASUGREL | prasugrel hydrochloride | TABLET;ORAL | 205927 | ANDA | Mylan Pharmaceuticals Inc. | 0378-5186 | 0378-5186-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5186-93) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Jul 12, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Jul 12, 2017 | TE: | AB | RLD: | No | ||||
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