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Details for New Drug Application (NDA): 075183
NDA 075183 describes PREDNISOLONE SODIUM PHOSPHATE, which is a drug marketed by Watson Labs, Akorn, Alcon Pharms Ltd, Bausch And Lomb, Sola Barnes Hind, Amneal Pharms, Chartwell Rx, Edenbridge Pharms, Hi Tech Pharma, Medicis Pharms, Mission Pharma, Nesher Pharms, Pharm Assoc, Vintage, Vintage Pharms, We Pharms, Wockhardt Bio Ag, and Mylan Pharms Inc, and is included in twenty-eight NDAs. It is available from nineteen suppliers. Additional details are available on the PREDNISOLONE SODIUM PHOSPHATE profile page.
The generic ingredient in PREDNISOLONE SODIUM PHOSPHATE is prednisolone sodium phosphate. There are eighty-six drug master file entries for this compound. Twenty-three 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 are eighty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
Summary for 075183
| Tradename: | PREDNISOLONE SODIUM PHOSPHATE |
| Applicant: | Hi Tech Pharma |
| Ingredient: | prednisolone sodium phosphate |
| Patents: | 0 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal) Inflammatory Bowel Disease Agents Ophthalmic Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075183
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 075183
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 075183 | ANDA | A-S Medication Solutions | 50090-1411 | N | 50090-1411-0 |
| PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 075183 | ANDA | Hi-Tech Pharmacal Co., Inc. | 50383-040 | N | 50383-040-04 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 5MG BASE/5ML | ||||
| Approval Date: | Mar 26, 2003 | TE: | AA | RLD: | No | ||||
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