Details for New Drug Application (NDA): 218980
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NDA 218980 describes KHINDIVI, which is a drug marketed by Eton and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the KHINDIVI profile page.
The generic ingredient in KHINDIVI is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
The generic ingredient in KHINDIVI is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
Summary for 218980
| Tradename: | KHINDIVI |
| Applicant: | Eton |
| Ingredient: | hydrocortisone |
| Patents: | 2 |
Pharmacology for NDA: 218980
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 218980
Suppliers and Packaging for NDA: 218980
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KHINDIVI | hydrocortisone | SOLUTION;ORAL | 218980 | NDA | Eton Pharmaceuticals, Inc. | 71863-116 | 71863-116-16 | 1 mL in 1 BOTTLE (71863-116-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
| Approval Date: | May 28, 2025 | TE: | RLD: | Yes | |||||
| Patent: | 11,904,046 | Patent Expiration: | Feb 23, 2043 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ADRENAL INSUFFICIENCY WITH AN ORAL LIQUID FORMULATION OF HYDROCORTISONE | ||||||||
| Patent: | 12,133,914 | Patent Expiration: | Feb 23, 2043 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PRIMARY OR SECONDARY ADRENOCORTICAL INSUFFICIENCY WITH AN ORAL LIQUID FORMULATION OF HYDROCORTISONE | ||||||||
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