Details for New Drug Application (NDA): 081203
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NDA 081203 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, Paddock Llc, Aurobindo Pharma Ltd, Barr, Elkins Sinn, Ferrante, Hikma Intl Pharms, Impax Labs, Impax Labs Inc, Inwood Labs, Nexgen Pharma Inc, Panray, Parke Davis, Purepac Pharm, Roxane, Sandoz, Strides Pharma, 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-three NDAs. It is available from twenty-nine 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 081203
| Tradename: | HYDROCORTISONE |
| Applicant: | Fougera Pharms Inc |
| Ingredient: | hydrocortisone |
| Patents: | 0 |
Pharmacology for NDA: 081203
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 081203
Suppliers and Packaging for NDA: 081203
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE | hydrocortisone | OINTMENT;TOPICAL | 081203 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0146 | 0168-0146-16 | 454 g in 1 JAR (0168-0146-16) |
| HYDROCORTISONE | hydrocortisone | OINTMENT;TOPICAL | 081203 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0146 | 0168-0146-30 | 29 g in 1 TUBE (0168-0146-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 2.5% | ||||
| Approval Date: | May 28, 1993 | TE: | AT | RLD: | No | ||||
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