DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 202179
NDA 202179 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-six 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-six 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 202179
| Tradename: | PREDNISOLONE SODIUM PHOSPHATE |
| Applicant: | Mylan Pharms Inc |
| 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: 202179
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 202179
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 202179 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4710 | N | 0378-4710-22 |
| PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 202179 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4715 | N | 0378-4715-22 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Apr 10, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 15MG BASE | ||||
| Approval Date: | Apr 10, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Apr 10, 2013 | TE: | AB | RLD: | No | ||||
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