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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 088759


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NDA 088759 describes HYDROCORTISONE AND ACETIC ACID, which is a drug marketed by Bausch And Lomb, Cosette, Taro, and Wockhardt, and is included in four NDAs. It is available from two suppliers. Additional details are available on the HYDROCORTISONE AND ACETIC ACID profile page.

The generic ingredient in HYDROCORTISONE AND ACETIC ACID is acetic acid, glacial; hydrocortisone. There are thirty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the acetic acid, glacial; hydrocortisone profile page.
Summary for 088759
Pharmacology for NDA: 088759
Suppliers and Packaging for NDA: 088759
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE AND ACETIC ACID acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 088759 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-3007 51672-3007-1 1 BOTTLE in 1 CARTON (51672-3007-1) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrength2%;1%
Approval Date:Mar 4, 1985TE:ATRLD:Yes

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