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Generated: November 19, 2018

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Details for New Drug Application (NDA): 017011

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NDA 017011 describes PRED FORTE, which is a drug marketed by Allergan and is included in one NDA. It is available from five suppliers. Additional details are available on the PRED FORTE profile page.

The generic ingredient in PRED FORTE 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 017011
Tradename:PRED FORTE
Applicant:Allergan
Ingredient:prednisolone acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017011
Suppliers and Packaging for NDA: 017011
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRED FORTE prednisolone acetate SUSPENSION/DROPS;OPHTHALMIC 017011 NDA Allergan, Inc. 11980-180 11980-180-01 1 BOTTLE, DROPPER in 1 CARTON (11980-180-01) > 1 mL in 1 BOTTLE, DROPPER
PRED FORTE prednisolone acetate SUSPENSION/DROPS;OPHTHALMIC 017011 NDA Allergan, Inc. 11980-180 11980-180-05 1 BOTTLE, DROPPER in 1 CARTON (11980-180-05) > 5 mL in 1 BOTTLE, DROPPER

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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