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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 040070


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NDA 040070 describes PREDNISOLONE SODIUM PHOSPHATE, which is a drug marketed by Watson Labs, Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Sola Barnes Hind, Amneal, Amneal Pharms, Bausch, Chartwell Rx, Edenbridge Pharms, Hikma, Mission Pharma, Nesher Pharms, Pharm Assoc, Pharmobedient Cnsltg, Vintage, Vintage Pharms, We Pharms, Xttrium Labs Inc, and Rising, and is included in thirty NDAs. It is available from eleven suppliers. Additional details are available on the PREDNISOLONE SODIUM PHOSPHATE profile page.

The generic ingredient in PREDNISOLONE SODIUM PHOSPHATE 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 040070
Tradename:PREDNISOLONE SODIUM PHOSPHATE
Applicant:Bausch And Lomb
Ingredient:prednisolone sodium phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040070
Suppliers and Packaging for NDA: 040070
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION/DROPS;OPHTHALMIC 040070 ANDA Bausch & Lomb Incorporated 24208-715 24208-715-10 1 BOTTLE, DROPPER in 1 CARTON (24208-715-10) / 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.9% PHOSPHATE
Approval Date:Jul 29, 1994TE:RLD:No

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