Details for New Drug Application (NDA): 040646
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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 040646
Tradename: | HYDROCORTISONE |
Applicant: | Impax Labs Inc |
Ingredient: | hydrocortisone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040646
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 040646
Suppliers and Packaging for NDA: 040646
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 040646 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1696 | 0115-1696-06 | 50 TABLET in 1 BOTTLE, PLASTIC (0115-1696-06) |
HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 040646 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1697 | 0115-1697-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0115-1697-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Mar 30, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 30, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Mar 30, 2007 | TE: | AB | RLD: | No |
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