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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 084305


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NDA 084305 describes MYDRIACYL, which is a drug marketed by Alcon, Alcon Labs Inc, and Sandoz, and is included in three NDAs. It is available from two suppliers. Additional details are available on the MYDRIACYL profile page.

The generic ingredient in MYDRIACYL is tropicamide. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tropicamide profile page.
Summary for 084305
Tradename:MYDRIACYL
Applicant:Sandoz
Ingredient:tropicamide
Patents:0
Pharmacology for NDA: 084305
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 084305
Suppliers and Packaging for NDA: 084305
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYDRIACYL tropicamide SOLUTION/DROPS;OPHTHALMIC 084305 ANDA Sandoz Inc 61314-354 61314-354-01 1 BOTTLE, PLASTIC in 1 CARTON (61314-354-01) / 15 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

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