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Last Updated: July 8, 2020

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Details for New Drug Application (NDA): 084305

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NDA 084305 describes MYDRIACYL, which is a drug marketed by Alcon, Novartis Pharms Corp, and Sandoz Inc, 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. Six suppliers are listed for this compound. Additional details are available on the tropicamide profile page.
Summary for 084305
Applicant:Sandoz Inc
Formulation / Manufacturing:see details
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:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim

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