Paremyd
PAREMYD
Approved
Approval ID
da8a8a19-ac1b-4160-aac4-c4c57598eb5d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2022
Manufacturers
FDA
Akorn
DUNS: 117693100
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydroxyamphetamine hydrobromide, tropicamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17478-704
Application NumberNDA019261
Product Classification
M
Marketing Category
C73594
G
Generic Name
Hydroxyamphetamine hydrobromide, tropicamide
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 30, 2012
FDA Product Classification
INGREDIENTS (8)
TropicamideActive
Quantity: 2.5 mg in 1 mL
Code: N0A3Z5XTC6
Classification: ACTIB
Hydroxyamphetamine hydrobromideActive
Quantity: 10 mg in 1 mL
Code: 59IG47SZ0E
Classification: ACTIB
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT