Details for New Drug Application (NDA): 219500
✉ Email this page to a colleague
NDA 219500 describes ENBUMYST, which is a drug marketed by Corstasis Therap and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the ENBUMYST profile page.
The generic ingredient in ENBUMYST is bumetanide. There are six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
The generic ingredient in ENBUMYST is bumetanide. There are six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 219500
| Tradename: | ENBUMYST |
| Applicant: | Corstasis Therap |
| Ingredient: | bumetanide |
| Patents: | 3 |
Pharmacology for NDA: 219500
| Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 219500
Suppliers and Packaging for NDA: 219500
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENBUMYST | bumetanide | SPRAY;NASAL | 219500 | NDA | Renaissance Lakewood LLC | 49396-0050 | 49396-0050-2 | 12 BLISTER PACK in 1 CARTON (49396-0050-2) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE |
| ENBUMYST | bumetanide | SPRAY;NASAL | 219500 | NDA | Renaissance Lakewood LLC | 49396-0050 | 49396-0050-6 | 6 BLISTER PACK in 1 CARTON (49396-0050-6) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | 0.5MG/SPRAY | ||||
| Approval Date: | Sep 12, 2025 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Dec 4, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Dec 4, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | INTRANASAL BUMETANIDE FOR THE TREATMENT OF EDEMA | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Dec 4, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | INTRANASAL BUMETANIDE FOR THE TREATMENT OF EDEMA | ||||||||
Complete Access Available with Subscription
