Details for New Drug Application (NDA): 088799
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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 088799
Tradename: | HYDROCORTISONE |
Applicant: | Taro |
Ingredient: | hydrocortisone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 088799
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 088799
Suppliers and Packaging for NDA: 088799
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE | hydrocortisone | CREAM;TOPICAL | 088799 | ANDA | Sun Pharmaceutical Industries, Inc. | 10631-407 | 10631-407-01 | 1 TUBE in 1 CARTON (10631-407-01) / 28.35 g in 1 TUBE |
HYDROCORTISONE | hydrocortisone | CREAM;TOPICAL | 088799 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-3003 | 51672-3003-0 | 1 TUBE in 1 CARTON (51672-3003-0) / 20 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 2.5% | ||||
Approval Date: | Nov 9, 1984 | TE: | AT | RLD: | No |
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