Details for New Drug Application (NDA): 211415
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NDA 211415 describes QUZYTTIR, which is a drug marketed by JDP and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the QUZYTTIR profile page.
The generic ingredient in QUZYTTIR is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
The generic ingredient in QUZYTTIR is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 211415
| Tradename: | QUZYTTIR |
| Applicant: | Jdp |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 5 |
Pharmacology for NDA: 211415
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 211415
Suppliers and Packaging for NDA: 211415
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUZYTTIR | cetirizine hydrochloride | SOLUTION;INTRAVENOUS | 211415 | NDA | TerSera Therapeutics LLC | 70720-100 | 70720-100-10 | 1 VIAL, GLASS in 1 CARTON (70720-100-10) / 1 mL in 1 VIAL, GLASS (70720-100-01) |
| QUZYTTIR | cetirizine hydrochloride | SOLUTION;INTRAVENOUS | 211415 | NDA | TerSera Therapeutics LLC | 70720-100 | 70720-100-25 | 25 VIAL, GLASS in 1 CARTON (70720-100-25) / 1 mL in 1 VIAL, GLASS (70720-100-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/ML (10MG/ML) | ||||
| Approval Date: | Oct 4, 2019 | TE: | RLD: | Yes | |||||
| Patent: | 8,263,581 | Patent Expiration: | Feb 28, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ACUTE URTICARIA | ||||||||
| Patent: | 8,314,083 | Patent Expiration: | Feb 28, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATMENT IN PATIENTS WITH CONCOMITANT ANGIOEDEMA | ||||||||
| Patent: | 8,513,259 | Patent Expiration: | Feb 11, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF INCREASING PEAK PLASMA OR ONSET OF PLASMA CONCENTRATION BY INTRAVENOUS INJECTION IN INDIVIDUALS IN NEED OF TREATMENT FOR ACUTE URTICARIA | ||||||||
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