Details for New Drug Application (NDA): 213315
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NDA 213315 describes PRASUGREL HYDROCHLORIDE, which is a drug marketed by Unichem and is included in one NDA. It is available from one supplier. Additional details are available on the PRASUGREL HYDROCHLORIDE profile page.
The generic ingredient in PRASUGREL HYDROCHLORIDE 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 HYDROCHLORIDE 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 213315
| Tradename: | PRASUGREL HYDROCHLORIDE |
| Applicant: | Unichem |
| Ingredient: | prasugrel hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213315
| Mechanism of Action | P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Medical Subject Heading (MeSH) Categories for 213315
Suppliers and Packaging for NDA: 213315
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRASUGREL HYDROCHLORIDE | prasugrel hydrochloride | TABLET;ORAL | 213315 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-301 | 29300-301-13 | 30 TABLET, FILM COATED in 1 BOTTLE (29300-301-13) |
| PRASUGREL HYDROCHLORIDE | prasugrel hydrochloride | TABLET;ORAL | 213315 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-302 | 29300-302-13 | 30 TABLET, FILM COATED in 1 BOTTLE (29300-302-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Aug 28, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Aug 28, 2023 | TE: | AB | RLD: | No | ||||
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