Details for New Drug Application (NDA): 203810
NDA 203810 describes HYDROCORTISONE, which is a drug marketed by Actavis Mid Atlantic, Alpharma Us Pharms, Altana, Ambix, Chartwell Molecular, Encube, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Naska, Padagis Us, Perrigo New York, Pharmaderm, Pharmafair, Rising, Stiefel, Syosset, Taro, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Teva Pharms, Fougera Pharms, Mericon, Sun Pharma Canada, Paddock Llc, Adaptis, Appco, Aurobindo Pharma Ltd, Barr, Elkins Sinn, Ferrante, Hikma, Impax Labs, Impax Labs Inc, Inwood Labs, Nexgen Pharma Inc, Novitium Pharma, Panray, Parke Davis, Purepac Pharm, Roxane, Sandoz, Strides Pharma, Strides Pharma Intl, Watson Labs, Cenci, Imperium, Bel Mar, Epic Pharma Llc, Sciegen Pharms, X Gen Pharms, Genus, Bausch And Lomb, Cosette Pharms Nc, Wockhardt, Glenmark Pharms Ltd, Taro Pharm Inds, Lupin, The J Molner, Pharmobedient, Abraxis Pharm, Apotex, Baxter Hlthcare, Cipla, Intl Medication, Zydus Pharms, Encube Ethicals, and Padagis Israel, and is included in one hundred and thirty-nine NDAs. It is available from thirty suppliers. Additional details are available on the HYDROCORTISONE profile page.
The generic ingredient in HYDROCORTISONE is hydrocortisone valerate. There are seven drug master file entries 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 is hydrocortisone valerate. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.
Summary for 203810
| Tradename: | HYDROCORTISONE |
| Applicant: | Encube |
| Ingredient: | hydrocortisone |
| Patents: | 0 |
Pharmacology for NDA: 203810
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 203810
Suppliers and Packaging for NDA: 203810
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE | hydrocortisone | CREAM;TOPICAL | 203810 | ANDA | Encube Ethicals, Inc. | 21922-065 | 21922-065-05 | 1 TUBE in 1 CARTON (21922-065-05) / 30 g in 1 TUBE |
| HYDROCORTISONE | hydrocortisone | CREAM;TOPICAL | 203810 | ANDA | Encube Ethicals, Inc. | 21922-065 | 21922-065-30 | 453.6 g in 1 JAR (21922-065-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 2.5% | ||||
| Approval Date: | Jul 23, 2018 | TE: | AT | RLD: | No | ||||
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