Details for New Drug Application (NDA): 021959
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NDA 021959 describes ORAPRED ODT, which is a drug marketed by Advanz Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the ORAPRED ODT profile page.
The generic ingredient in ORAPRED ODT is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
The generic ingredient in ORAPRED ODT is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
Summary for 021959
| Tradename: | ORAPRED ODT |
| Applicant: | Advanz Pharma |
| Ingredient: | prednisolone sodium phosphate |
| Patents: | 0 |
Pharmacology for NDA: 021959
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 021959
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959 | NDA AUTHORIZED GENERIC | Ingenus Pharmaceuticals, LLC | 50742-383 | 50742-383-12 | 2 BLISTER PACK in 1 CARTON (50742-383-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50742-383-06) |
| ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959 | NDA AUTHORIZED GENERIC | Ingenus Pharmaceuticals, LLC | 50742-384 | 50742-384-12 | 2 BLISTER PACK in 1 CARTON (50742-384-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50742-384-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Jun 1, 2006 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 15MG BASE | ||||
| Approval Date: | Jun 1, 2006 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Jun 1, 2006 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021959
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Advanz Pharma | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-002 | Jun 1, 2006 | ⤷ Get Started Free | ⤷ Get Started Free |
| Advanz Pharma | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-003 | Jun 1, 2006 | ⤷ Get Started Free | ⤷ Get Started Free |
| Advanz Pharma | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-001 | Jun 1, 2006 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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