Details for New Drug Application (NDA): 075042
NDA 075042 describes HYDROCORTISONE VALERATE, which is a drug marketed by Cosette Pharms Nc, Encube Ethicals, Glenmark Pharms Ltd, Lupin, Padagis Israel, Sun Pharma Canada, and Fougera Pharms, and is included in eleven NDAs. It is available from five suppliers. Additional details are available on the HYDROCORTISONE VALERATE profile page.
The generic ingredient in HYDROCORTISONE VALERATE is hydrocortisone valerate. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.
The generic ingredient in HYDROCORTISONE VALERATE is hydrocortisone valerate. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.
Summary for 075042
| Tradename: | HYDROCORTISONE VALERATE |
| Applicant: | Sun Pharma Canada |
| Ingredient: | hydrocortisone valerate |
| Patents: | 0 |
Pharmacology for NDA: 075042
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 075042
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE VALERATE | hydrocortisone valerate | CREAM;TOPICAL | 075042 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-1290 | 51672-1290-1 | 1 TUBE in 1 CARTON (51672-1290-1) / 15 g in 1 TUBE |
| HYDROCORTISONE VALERATE | hydrocortisone valerate | CREAM;TOPICAL | 075042 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-1290 | 51672-1290-3 | 1 TUBE in 1 CARTON (51672-1290-3) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.2% | ||||
| Approval Date: | Aug 25, 1998 | TE: | AB | RLD: | No | ||||
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