Details for New Drug Application (NDA): 219500
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NDA 219500 describes ENBUMYST, which is a drug marketed by Corstasis Therap and is included in one NDA. It is available from one supplier. 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. Forty 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. Forty 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 | Corstasis USA LLC | 84388-005 | 84388-005-06 | 6 BLISTER PACK in 1 CARTON (84388-005-06) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE |
| ENBUMYST | bumetanide | SPRAY;NASAL | 219500 | NDA | Corstasis USA LLC | 84388-005 | 84388-005-12 | 12 BLISTER PACK in 1 CARTON (84388-005-12) / 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: | 11,123,319 | Patent Expiration: | Dec 4, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,260,038 | Patent Expiration: | Dec 4, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | INTRANASAL BUMETANIDE FOR THE TREATMENT OF EDEMA | ||||||||
| Patent: | 12,329,731 | Patent Expiration: | Dec 4, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | INTRANASAL BUMETANIDE FOR THE TREATMENT OF EDEMA | ||||||||
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