Details for New Drug Application (NDA): 040879
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The generic ingredient in HYDROCORTISONE is hydrocortisone valerate. There are sixty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.
Summary for 040879
Tradename: | HYDROCORTISONE |
Applicant: | Rising |
Ingredient: | hydrocortisone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040879
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 040879
Suppliers and Packaging for NDA: 040879
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE | hydrocortisone | CREAM;TOPICAL | 040879 | ANDA | Bryant Ranch Prepack | 63629-2396 | 63629-2396-1 | 1 TUBE in 1 CARTON (63629-2396-1) / 30 g in 1 TUBE |
HYDROCORTISONE | hydrocortisone | CREAM;TOPICAL | 040879 | ANDA | Bryant Ranch Prepack | 63629-8847 | 63629-8847-1 | 1 TUBE in 1 CARTON (63629-8847-1) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 2.5% | ||||
Approval Date: | Aug 20, 2010 | TE: | AT | RLD: | No |
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