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Generated: November 13, 2018

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Details for New Drug Application (NDA): 017469

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NDA 017469 describes OMNIPRED, which is a drug marketed by Novartis Pharms Corp 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. Ten suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.
Summary for 017469
Tradename:OMNIPRED
Applicant:Novartis Pharms Corp
Ingredient:prednisolone acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017469
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 Alcon Laboratories, Inc. 0065-0638 0065-0638-25 10 mL in 1 BOTTLE, PLASTIC (0065-0638-25)
OMNIPRED prednisolone acetate SUSPENSION/DROPS;OPHTHALMIC 017469 NDA Alcon Laboratories, Inc. 0065-0638 0065-0638-27 5 mL in 1 BOTTLE, PLASTIC (0065-0638-27)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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