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Last Updated: April 12, 2024

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 are eighty-eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.
Summary for 017469
Ingredient:prednisolone acetate
Formulation / Manufacturing:see details
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:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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