Details for New Drug Application (NDA): 040646
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NDA 040646 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, Appco, 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 Pharms Nc, Wockhardt, Glenmark Pharms Ltd, Taro Pharm Inds, Lupin, The J Molner, Cmp Pharma Inc, 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-one 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. 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 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 040646
| Tradename: | HYDROCORTISONE |
| Applicant: | Impax Labs Inc |
| Ingredient: | hydrocortisone |
| Patents: | 0 |
Pharmacology for NDA: 040646
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 040646
Suppliers and Packaging for NDA: 040646
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 040646 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1696 | 0115-1696-06 | 50 TABLET in 1 BOTTLE, PLASTIC (0115-1696-06) |
| HYDROCORTISONE | hydrocortisone | TABLET;ORAL | 040646 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1697 | 0115-1697-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0115-1697-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Mar 30, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Mar 30, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Mar 30, 2007 | TE: | AB | RLD: | No | ||||
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