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Last Updated: May 30, 2023

Details for New Drug Application (NDA): 013422

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NDA 013422 describes MAXIDEX, which is a drug marketed by Alcon and Novartis and is included in two NDAs. It is available from two suppliers. Additional details are available on the MAXIDEX profile page.

The generic ingredient in MAXIDEX is dexamethasone. There are thirty-nine drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
Summary for 013422
Formulation / Manufacturing:see details
Pharmacology for NDA: 013422
Medical Subject Heading (MeSH) Categories for 013422
Suppliers and Packaging for NDA: 013422
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAXIDEX dexamethasone SUSPENSION/DROPS;OPHTHALMIC 013422 NDA Novartis Pharmaceuticals Corporation 0078-0925 0078-0925-25 5 mL in 1 BOTTLE (0078-0925-25)
MAXIDEX dexamethasone SUSPENSION/DROPS;OPHTHALMIC 013422 NDA Alcon Laboratories, Inc. 0998-0615 0998-0615-05 5 mL in 1 BOTTLE, PLASTIC (0998-0615-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Harvard Business School
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Johnson and Johnson

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