Details for New Drug Application (NDA): 216379
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NDA 216379 describes TIROFIBAN HYDROCHLORIDE, which is a drug marketed by Eugia Pharma, Gland Pharma Ltd, and Nexus, and is included in three NDAs. It is available from three suppliers. Additional details are available on the TIROFIBAN HYDROCHLORIDE profile page.
The generic ingredient in TIROFIBAN HYDROCHLORIDE is tirofiban hydrochloride. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.
The generic ingredient in TIROFIBAN HYDROCHLORIDE is tirofiban hydrochloride. There are four drug master file entries for this compound. Four 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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