Details for New Drug Application (NDA): 040323
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The generic ingredient in PREDNISOLONE is prednisolone tebutate. There are eighty-eight drug master file entries for this compound. Additional details are available on the prednisolone tebutate profile page.
Summary for 040323
Tradename: | PREDNISOLONE |
Applicant: | Chartwell Rx |
Ingredient: | prednisolone |
Patents: | 0 |
Pharmacology for NDA: 040323
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 040323
Suppliers and Packaging for NDA: 040323
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREDNISOLONE | prednisolone | SYRUP;ORAL | 040323 | ANDA | Chartwell RX, LLC | 62135-250 | 62135-250-24 | 2 TRAY in 1 BOX (62135-250-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-250-45) |
PREDNISOLONE | prednisolone | SYRUP;ORAL | 040323 | ANDA | Chartwell RX, LLC | 62135-250 | 62135-250-37 | 240 mL in 1 BOTTLE (62135-250-37) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 15MG/5ML | ||||
Approval Date: | May 13, 1999 | TE: | AA | RLD: | No |
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