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Generated: November 19, 2018

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Details for New Drug Application (NDA): 016968

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NDA 016968 describes MIOSTAT, which is a drug marketed by Alcon and is included in one NDA. It is available from one supplier. Additional details are available on the MIOSTAT profile page.

The generic ingredient in MIOSTAT is carbachol. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the carbachol profile page.
Summary for 016968
Formulation / Manufacturing:see details
Pharmacology for NDA: 016968
Mechanism of ActionCholinergic Agonists
Medical Subject Heading (MeSH) Categories for 016968
Suppliers and Packaging for NDA: 016968
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIOSTAT carbachol SOLUTION;INTRAOCULAR 016968 NDA Alcon Laboratories, Inc. 0065-0023 0065-0023-15 12 VIAL, GLASS in 1 CARTON (0065-0023-15) > 1.5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAOCULARStrength0.01%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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