Details for New Drug Application (NDA): 210872
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NDA 210872 describes ZURAGARD, which is a drug marketed by Zurex Pharma and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the ZURAGARD profile page.
The generic ingredient in ZURAGARD is isopropyl alcohol. There are thirty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the isopropyl alcohol profile page.
The generic ingredient in ZURAGARD is isopropyl alcohol. There are thirty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the isopropyl alcohol profile page.
Summary for 210872
| Tradename: | ZURAGARD |
| Applicant: | Zurex Pharma |
| Ingredient: | isopropyl alcohol |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210872
Generic Entry Date for 210872*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 210872
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZURAGARD | isopropyl alcohol | SOLUTION;TOPICAL | 210872 | NDA | Zurex Pharma, Inc. | 49823-100 | 49823-100-01 | 25 POUCH in 1 CARTON (49823-100-01) / 10.5 mL in 1 POUCH |
| ZURAGARD | isopropyl alcohol | SOLUTION;TOPICAL | 210872 | NDA | Zurex Pharma, Inc. | 49823-100 | 49823-100-02 | 25 POUCH in 1 BOX (49823-100-02) / 26 mL in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;TOPICAL | Strength | 70% | ||||
| Approval Date: | Apr 26, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 24, 2024 | ||||||||
| Regulatory Exclusivity Use: | ADDITION OF INFORMATION TO THE LABEL REGARDING A CLEAR PRODUCT PRESENTATION AND 26 ML VOLUME PRODUCTS | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Dec 20, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 6, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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