Details for New Drug Application (NDA): 203559
✉ Email this page to a colleague
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 203559
Tradename: | PREDNISOLONE SODIUM PHOSPHATE |
Applicant: | Edenbridge Pharms |
Ingredient: | prednisolone sodium phosphate |
Patents: | 0 |
Pharmacology for NDA: 203559
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 203559
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 203559 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-812 | 42799-812-01 | 237 mL in 1 BOTTLE, PLASTIC (42799-812-01) |
PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 203559 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-813 | 42799-813-01 | 237 mL in 1 BOTTLE, PLASTIC (42799-813-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 10MG BASE/5ML | ||||
Approval Date: | Dec 20, 2016 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 20MG BASE/5ML | ||||
Approval Date: | Dec 20, 2016 | TE: | AA | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 15MG BASE/5ML | ||||
Approval Date: | Feb 6, 2023 | TE: | AA | RLD: | No |
Complete Access Available with Subscription