Details for New Drug Application (NDA): 203559
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NDA 203559 describes PREDNISOLONE SODIUM PHOSPHATE, which is a drug marketed by Watson Labs, Alcon Pharms Ltd, Bausch And Lomb, Bausch And Lomb Inc, Epic Pharma Llc, Sola Barnes Hind, Amneal, Amneal Pharms, Bausch, Chartwell Rx, Edenbridge Pharms, Hikma, Mission Pharma, Nesher Pharms, Ph Health, Pharm Assoc, Pharmobedient, Pharmobedient Cnsltg, Vintage Pharms, We Pharms, and Rising, and is included in thirty NDAs. It is available from sixteen suppliers. Additional details are available on the PREDNISOLONE SODIUM PHOSPHATE profile page.
The generic ingredient in PREDNISOLONE SODIUM PHOSPHATE is prednisolone sodium phosphate. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
The generic ingredient in PREDNISOLONE SODIUM PHOSPHATE is prednisolone sodium phosphate. There is one drug master file entry for this compound. Nineteen 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 | ATLANTIC BIOLOGICALS CORP. | 17856-0815 | 17856-0815-1 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0815-1) / 5 mL in 1 CUP, UNIT-DOSE |
| PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 203559 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0815 | 17856-0815-2 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0815-2) / 10 mL in 1 CUP, UNIT-DOSE |
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 | ||||
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