Details for New Drug Application (NDA): 040396
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NDA 040396 describes MICORT-HC, which is a drug marketed by Legacy Pharma 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 are sixty-seven drug master file entries 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 are sixty-seven drug master file entries 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 Pharma |
| 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 Holdings LLC | 71297-241 | 71297-241-01 | 28.4 g in 1 CARTON (71297-241-01) |
| MICORT-HC | hydrocortisone acetate | CREAM;TOPICAL | 040396 | ANDA | Legacy Pharma USA Inc. | 83107-026 | 83107-026-01 | 28.4 g in 1 CARTON (83107-026-01) |
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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