Details for New Drug Application (NDA): 206888
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NDA 206888 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 four 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.
Summary for 206888
| Tradename: | TIROFIBAN HYDROCHLORIDE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | tirofiban hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 206888
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 206888
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIROFIBAN HYDROCHLORIDE | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 206888 | ANDA | Sagent Pharmaceuticals | 25021-417 | 25021-417-84 | 1 BAG in 1 CARTON (25021-417-84) / 250 mL in 1 BAG |
| TIROFIBAN HYDROCHLORIDE | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 206888 | ANDA | Gland Pharma Limited | 68083-145 | 68083-145-01 | 1 CONTAINER in 1 CARTON (68083-145-01) / 250 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | ||||
| Approval Date: | Apr 8, 2021 | TE: | AP | RLD: | No | ||||
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