Details for New Drug Application (NDA): 216379
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The generic ingredient in TIROFIBAN HYDROCHLORIDE is tirofiban hydrochloride. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.
Summary for 216379
Tradename: | TIROFIBAN HYDROCHLORIDE |
Applicant: | Eugia Pharma |
Ingredient: | tirofiban hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 216379
Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 216379
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TIROFIBAN HYDROCHLORIDE | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 216379 | ANDA | Eugia US LLC | 55150-429 | 55150-429-01 | 1 POUCH in 1 CARTON (55150-429-01) / 1 BAG in 1 POUCH / 100 mL in 1 BAG |
TIROFIBAN HYDROCHLORIDE | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 216379 | ANDA | Eugia US LLC | 55150-430 | 55150-430-01 | 1 POUCH in 1 CARTON (55150-430-01) / 1 BAG in 1 POUCH / 250 mL in 1 BAG |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | ||||
Approval Date: | May 1, 2023 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | ||||
Approval Date: | May 1, 2023 | TE: | AP | RLD: | No |
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