Details for New Drug Application (NDA): 019157
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The generic ingredient in PEDIAPRED is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
Summary for 019157
Tradename: | PEDIAPRED |
Applicant: | Seton Pharm |
Ingredient: | prednisolone sodium phosphate |
Patents: | 0 |
Pharmacology for NDA: 019157
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 019157
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PEDIAPRED | prednisolone sodium phosphate | SOLUTION;ORAL | 019157 | NDA | Seton Pharmaceuticals, LLC | 13925-166 | 13925-166-04 | 120 mL in 1 BOTTLE (13925-166-04) |
PEDIAPRED | prednisolone sodium phosphate | SOLUTION;ORAL | 019157 | NDA | Royal Pharmaceuticals | 68791-104 | 68791-104-04 | 120 mL in 1 BOTTLE (68791-104-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 5MG BASE/5ML | ||||
Approval Date: | May 28, 1986 | TE: | AA | RLD: | Yes |
Expired US Patents for NDA 019157
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Seton Pharm | PEDIAPRED | prednisolone sodium phosphate | SOLUTION;ORAL | 019157-001 | May 28, 1986 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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