Details for New Drug Application (NDA): 211764
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NDA 211764 describes HYDROCORTISONE VALERATE, which is a drug marketed by Cosette, Encube Ethicals, Glenmark Pharms Ltd, Lupin Ltd, Padagis Israel, Taro, and Fougera Pharms, and is included in eleven NDAs. It is available from six suppliers. Additional details are available on the HYDROCORTISONE VALERATE profile page.
The generic ingredient in HYDROCORTISONE VALERATE is hydrocortisone valerate. There are sixty-seven drug master file entries for this compound. Six 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 are sixty-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.
Summary for 211764
| Tradename: | HYDROCORTISONE VALERATE |
| Applicant: | Cosette |
| Ingredient: | hydrocortisone valerate |
| Patents: | 0 |
Pharmacology for NDA: 211764
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 211764
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE VALERATE | hydrocortisone valerate | OINTMENT;TOPICAL | 211764 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0560 | 0713-0560-15 | 1 TUBE in 1 CARTON (0713-0560-15) / 15 g in 1 TUBE |
| HYDROCORTISONE VALERATE | hydrocortisone valerate | OINTMENT;TOPICAL | 211764 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0560 | 0713-0560-37 | 1 TUBE in 1 CARTON (0713-0560-37) / 45 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.2% | ||||
| Approval Date: | Mar 4, 2020 | TE: | AB | RLD: | No | ||||
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