Details for New Drug Application (NDA): 085070
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The generic ingredient in HYDROCORTISONE is hydrocortisone valerate. There are sixty-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.
Summary for 085070
Tradename: | HYDROCORTISONE |
Applicant: | Chartwell Molecular |
Ingredient: | hydrocortisone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 085070
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 085070
Suppliers and Packaging for NDA: 085070
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 085070 | ANDA | Chartwell RX, LLC | 62135-186 | 62135-186-60 | 60 TABLET in 1 BOTTLE (62135-186-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
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