MYDCOMBI
These highlights do not include all the information needed to use MYDCOMBI safely and effectively. See full prescribing information for MYDCOMBI. MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%, for topical ophthalmic use Initial U.S. Approval: 2023
Approved
Approval ID
dbff7eeb-a16a-4106-ae5e-4effdd33cc45
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 9, 2023
Manufacturers
FDA
Eyenovia, Inc.
DUNS: 081032969
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tropicamide and Phenylephrine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81046-0111
Application NumberNDA215352
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tropicamide and Phenylephrine Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 9, 2023
FDA Product Classification
INGREDIENTS (6)
TropicamideActive
Quantity: 0.08 mg in 0.008 mL
Code: N0A3Z5XTC6
Classification: ACTIB
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Phenylephrine HydrochlorideActive
Quantity: 0.2 mg in 0.008 mL
Code: 04JA59TNSJ
Classification: ACTIB
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT