Details for New Drug Application (NDA): 017469
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NDA 017469 describes OMNIPRED, which is a drug marketed by Sandoz and is included in one NDA. It is available from three suppliers. Additional details are available on the OMNIPRED profile page.
The generic ingredient in OMNIPRED is prednisolone acetate. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.
The generic ingredient in OMNIPRED is prednisolone acetate. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.
Summary for 017469
| Tradename: | OMNIPRED |
| Applicant: | Sandoz |
| Ingredient: | prednisolone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 017469
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMNIPRED | prednisolone acetate | SUSPENSION/DROPS;OPHTHALMIC | 017469 | NDA AUTHORIZED GENERIC | A-S Medication Solutions | 50090-0559 | 50090-0559-0 | 1 BOTTLE, PLASTIC in 1 CARTON (50090-0559-0) / 10 mL in 1 BOTTLE, PLASTIC |
| OMNIPRED | prednisolone acetate | SUSPENSION/DROPS;OPHTHALMIC | 017469 | NDA AUTHORIZED GENERIC | Sandoz Inc | 61314-637 | 61314-637-05 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-637-05) / 5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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