Details for New Drug Application (NDA): 080694
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NDA 080694 describes CORTISONE ACETATE, which is a drug marketed by Pharmacia And Upjohn, Watson Labs, Barr, Chartwell Molecular, Elkins Sinn, Everylife, Heather, Hikma Intl Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Panray, Purepac Pharm, Vitarine, and Whiteworth Town Plsn, and is included in eighteen NDAs. It is available from one supplier. Additional details are available on the CORTISONE ACETATE profile page.
The generic ingredient in CORTISONE ACETATE is cortisone acetate. There are seventy-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cortisone acetate profile page.
The generic ingredient in CORTISONE ACETATE is cortisone acetate. There are seventy-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cortisone acetate profile page.
Summary for 080694
| Tradename: | CORTISONE ACETATE |
| Applicant: | Chartwell Molecular |
| Ingredient: | cortisone acetate |
| Patents: | 0 |
Pharmacology for NDA: 080694
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 080694
Suppliers and Packaging for NDA: 080694
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CORTISONE ACETATE | cortisone acetate | TABLET;ORAL | 080694 | ANDA | Chartwell RX, LLC | 62135-173 | 62135-173-30 | 30 TABLET in 1 PACKAGE (62135-173-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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