Details for New Drug Application (NDA): 210307
NDA 210307 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 210307
| Tradename: | HYDROCORTISONE VALERATE |
| Applicant: | Lupin |
| Ingredient: | hydrocortisone valerate |
| Patents: | 0 |
Pharmacology for NDA: 210307
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 210307
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE VALERATE | hydrocortisone valerate | CREAM;TOPICAL | 210307 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-954 | 68180-954-01 | 1 TUBE in 1 CARTON (68180-954-01) / 15 g in 1 TUBE |
| HYDROCORTISONE VALERATE | hydrocortisone valerate | CREAM;TOPICAL | 210307 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-954 | 68180-954-02 | 1 TUBE in 1 CARTON (68180-954-02) / 45 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.2% | ||||
| Approval Date: | Aug 15, 2019 | TE: | AB | RLD: | No | ||||
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