prasugrel

Product NDC

48792-7821

11-digit product format

487927821

Labeler code

48792

Product ID

48792-7821_80a41613-454b-2f59-e053-2991aa0aacdf

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Prasugrel hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Sunshine Lake Pharma Co., Ltd.

Application

ANDA206021

Marketing category

ANDA

Marketing start

2019-01-30

Marketing end

0000-00-00

Substance

PRASUGREL HYDROCHLORIDE

Active strength

10 mg/1

Pharmacologic classes

Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record