Details for New Drug Application (NDA): 076913
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The generic ingredient in PREDNISOLONE SODIUM PHOSPHATE 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 076913
Tradename: | PREDNISOLONE SODIUM PHOSPHATE |
Applicant: | Pharm Assoc |
Ingredient: | prednisolone sodium phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076913
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 076913
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 076913 | ANDA | PAI Holdings, LLC | 0121-0759 | 0121-0759-08 | 237 mL in 1 BOTTLE (0121-0759-08) |
PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 076913 | ANDA | PAI Holdings, LLC | 0121-4759 | 0121-4759-50 | 5 TRAY in 1 CASE (0121-4759-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4759-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 15MG BASE/5ML | ||||
Approval Date: | Apr 25, 2005 | TE: | AA | RLD: | No |
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