Mydriacyl
MYDRIACYL (tropicamide ophthalmic solution, USP)
Approved
Approval ID
57165763-29dc-4812-b840-a8a5086416f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2022
Manufacturers
FDA
Alcon Laboratories, Inc.
DUNS: 008018525
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tropicamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0065-0355
Application NumberANDA084306
Product Classification
M
Marketing Category
C73584
G
Generic Name
tropicamide
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 28, 2019
FDA Product Classification
INGREDIENTS (7)
TROPICAMIDEActive
Quantity: 10 mg in 1 mL
Code: N0A3Z5XTC6
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT