Details for New Drug Application (NDA): 209556
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NDA 209556 describes HYDROCORTISONE BUTYRATE, which is a drug marketed by Actavis Mid Atlantic, Glenmark Pharms Ltd, Taro Pharm Inds, Lupin Ltd, The J Molner, and Taro, and is included in seven NDAs. It is available from four suppliers. Additional details are available on the HYDROCORTISONE BUTYRATE profile page.
The generic ingredient in HYDROCORTISONE BUTYRATE is hydrocortisone butyrate. 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 butyrate profile page.
The generic ingredient in HYDROCORTISONE BUTYRATE is hydrocortisone butyrate. 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 butyrate profile page.
Summary for 209556
| Tradename: | HYDROCORTISONE BUTYRATE |
| Applicant: | The J Molner |
| Ingredient: | hydrocortisone butyrate |
| Patents: | 0 |
Pharmacology for NDA: 209556
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 209556
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | LOTION;TOPICAL | 209556 | ANDA | The J. Molner Company LLC | 83148-012 | 83148-012-02 | 1 BOTTLE in 1 CARTON (83148-012-02) / 59 mL in 1 BOTTLE |
| HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | LOTION;TOPICAL | 209556 | ANDA | The J. Molner Company LLC | 83148-012 | 83148-012-04 | 1 BOTTLE in 1 CARTON (83148-012-04) / 118 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Nov 21, 2017 | TE: | AB | RLD: | No | ||||
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