Details for New Drug Application (NDA): 040396
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NDA 040396 describes MICORT-HC, which is a drug marketed by Legacy and is included in two NDAs. It is available from two suppliers. Additional details are available on the MICORT-HC profile page.
The generic ingredient in MICORT-HC is hydrocortisone acetate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate profile page.
The generic ingredient in MICORT-HC is hydrocortisone acetate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate profile page.
Summary for 040396
| Tradename: | MICORT-HC |
| Applicant: | Legacy |
| Ingredient: | hydrocortisone acetate |
| Patents: | 0 |
Pharmacology for NDA: 040396
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 040396
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MICORT-HC | hydrocortisone acetate | CREAM;TOPICAL | 040396 | ANDA | Allegis Pharmaceuticals, Inc. | 28595-050 | 28595-050-01 | 28.4 g in 1 CARTON (28595-050-01) |
| MICORT-HC | hydrocortisone acetate | CREAM;TOPICAL | 040396 | ANDA | Allegis Holdings LLC | 71297-241 | 71297-241-01 | 28.4 g in 1 CARTON (71297-241-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 2.5% | ||||
| Approval Date: | Feb 27, 2001 | TE: | RLD: | No | |||||
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