Details for New Drug Application (NDA): 040351
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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 040351
Tradename: | HYDROCORTISONE |
Applicant: | Fougera Pharms |
Ingredient: | hydrocortisone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040351
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 040351
Suppliers and Packaging for NDA: 040351
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE | hydrocortisone | LOTION;TOPICAL | 040351 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0288 | 0168-0288-02 | 59 mL in 1 BOTTLE (0168-0288-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | LOTION;TOPICAL | Strength | 2.5% | ||||
Approval Date: | Jul 25, 2000 | TE: | RLD: | No |
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