DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 075183
Join the DrugPatentWatch Referral Program Get access to a free drug patent landscape report or a free one-month subscription
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 fifteen 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-eight drug master file entries 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 are eighty-eight drug master file entries for this compound. Nineteen 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 |
| 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 | 50090-1411-0 | 120 mL in 1 BOTTLE (50090-1411-0) |
| PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 075183 | ANDA | Hi-Tech Pharmacal Co., Inc. | 50383-040 | 50383-040-04 | 120 mL in 1 BOTTLE (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 | ||||
Complete Access Available with Subscription
