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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 216935


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NDA 216935 describes PREDNISOLONE ACETATE, which is a drug marketed by Bel Mar, Cent Pharms, Epic Pharma Llc, Watson Labs, and Lupin Ltd, and is included in ten NDAs. It is available from one supplier. Additional details are available on the PREDNISOLONE ACETATE profile page.

The generic ingredient in PREDNISOLONE ACETATE is prednisolone acetate. There are eighty-eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.
Summary for 216935
Tradename:PREDNISOLONE ACETATE
Applicant:Lupin Ltd
Ingredient:prednisolone acetate
Patents:0
Pharmacology for NDA: 216935
Suppliers and Packaging for NDA: 216935
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREDNISOLONE ACETATE prednisolone acetate SUSPENSION/DROPS;OPHTHALMIC 216935 ANDA Lupin Pharmaceuticals, Inc. 70748-332 70748-332-02 1 BOTTLE in 1 CARTON (70748-332-02) / 5 mL in 1 BOTTLE
PREDNISOLONE ACETATE prednisolone acetate SUSPENSION/DROPS;OPHTHALMIC 216935 ANDA Lupin Pharmaceuticals, Inc. 70748-332 70748-332-03 1 BOTTLE in 1 CARTON (70748-332-03) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength1%
Approval Date:Aug 2, 2024TE:ABRLD:No

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