Details for New Drug Application (NDA): 217160
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NDA 217160 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, Aurobindo Pharma Ltd, Barr, Elkins Sinn, Ferrante, Hibrow Hlthcare, Hikma Intl Pharms, 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, Fera Pharms, X Gen Pharms, Genus, Bausch And Lomb, Cosette, Wockhardt, Glenmark Pharms Ltd, Taro Pharm Inds, Lupin Ltd, The J Molner, Cmp Pharma Inc, Abraxis Pharm, Baxter Hlthcare, Cipla, Intl Medication, Encube Ethicals, and Padagis Israel, and is included in one hundred and thirty-five 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 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 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 217160
| Tradename: | HYDROCORTISONE |
| Applicant: | Hibrow Hlthcare |
| Ingredient: | hydrocortisone |
| Patents: | 0 |
Pharmacology for NDA: 217160
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 217160
Suppliers and Packaging for NDA: 217160
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 217160 | ANDA | Eywa Pharma Inc | 71930-078 | 71930-078-50 | 50 TABLET in 1 BOTTLE (71930-078-50) |
| HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 217160 | ANDA | Eywa Pharma Inc | 71930-079 | 71930-079-12 | 100 TABLET in 1 BOTTLE (71930-079-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 25, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 25, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Nov 25, 2024 | TE: | AB | RLD: | No | ||||
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