Details for New Drug Application (NDA): 213876
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NDA 213876 describes ALKINDI SPRINKLE, which is a drug marketed by Eton 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 ALKINDI SPRINKLE profile page.
The generic ingredient in ALKINDI SPRINKLE is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
The generic ingredient in ALKINDI SPRINKLE is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.
Summary for 213876
| Tradename: | ALKINDI SPRINKLE |
| Applicant: | Eton |
| Ingredient: | hydrocortisone |
| Patents: | 3 |
Pharmacology for NDA: 213876
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 213876
Suppliers and Packaging for NDA: 213876
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALKINDI SPRINKLE | hydrocortisone | GRANULE;ORAL | 213876 | NDA | Eton Pharmaceuticals, Inc. | 71863-109 | 71863-109-50 | 1 BOTTLE, PLASTIC in 1 CARTON (71863-109-50) / 50 GRANULE in 1 BOTTLE, PLASTIC |
| ALKINDI SPRINKLE | hydrocortisone | GRANULE;ORAL | 213876 | NDA | Eton Pharmaceuticals, Inc. | 71863-110 | 71863-110-50 | 1 BOTTLE, PLASTIC in 1 CARTON (71863-110-50) / 50 GRANULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Sep 29, 2020 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 12, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ADRENAL INSUFFICIENCY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 10, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADRENAL INSUFFICIENCY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 19, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADRENAL INSUFFICIENCY | ||||||||
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