Details for New Drug Application (NDA): 211047
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NDA 211047 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 211047
| Tradename: | HYDROCORTISONE VALERATE |
| Applicant: | Encube Ethicals |
| Ingredient: | hydrocortisone valerate |
| Patents: | 0 |
Pharmacology for NDA: 211047
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 211047
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE VALERATE | hydrocortisone valerate | CREAM;TOPICAL | 211047 | ANDA | Encube Ethicals Private Limited | 21922-007 | 21922-007-04 | 1 TUBE in 1 CARTON (21922-007-04) / 15 g in 1 TUBE |
| HYDROCORTISONE VALERATE | hydrocortisone valerate | CREAM;TOPICAL | 211047 | ANDA | Encube Ethicals Private Limited | 21922-007 | 21922-007-06 | 1 TUBE in 1 CARTON (21922-007-06) / 45 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.2% | ||||
| Approval Date: | Nov 4, 2021 | TE: | AB | RLD: | No | ||||
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