Details for New Drug Application (NDA): 022307
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The generic ingredient in EFFIENT 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 022307
Tradename: | EFFIENT |
Applicant: | Cosette |
Ingredient: | prasugrel hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 022307
Mechanism of Action | P2Y12 Receptor Antagonists |
Physiological Effect | Decreased Platelet Aggregation |
Medical Subject Heading (MeSH) Categories for 022307
Suppliers and Packaging for NDA: 022307
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0881 | 0713-0881-30 | 30 TABLET, COATED in 1 BOTTLE (0713-0881-30) |
EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0882 | 0713-0882-30 | 30 TABLET, COATED in 1 BOTTLE (0713-0882-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Jul 10, 2009 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Jul 10, 2009 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 022307
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-001 | Jul 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-001 | Jul 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-001 | Jul 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | EFFIENT | prasugrel hydrochloride | TABLET;ORAL | 022307-002 | Jul 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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