Details for New Drug Application (NDA): 021959
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The generic ingredient in ORAPRED ODT is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
Summary for 021959
Tradename: | ORAPRED ODT |
Applicant: | Concordia Pharms Inc |
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 | Concordia Pharmaceuticals Inc. | 59212-700 | 59212-700-12 | 2 BLISTER PACK in 1 CARTON (59212-700-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59212-700-06) |
ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959 | NDA | Concordia Pharmaceuticals Inc. | 59212-701 | 59212-701-12 | 2 BLISTER PACK in 1 CARTON (59212-701-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59212-701-06) |
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 |
---|---|---|---|---|---|---|---|
Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-003 | Jun 1, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-001 | Jun 1, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-001 | Jun 1, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-002 | Jun 1, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-002 | Jun 1, 2006 | ⤷ Sign Up | ⤷ Sign Up |
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