Atropine
These highlights do not include all the information needed to use Atropine Sulfate Ophthalmic Solution, USP 1% safely and effectively. See full prescribing information for Atropine Sulfate Ophthalmic Solution, USP 1%.Atropine Sulfate Ophthalmic Solution, USP 1% for topical application to the eye.Initial U.S. Approval: 1960
Approved
Approval ID
590a4e7b-565f-415f-a8e4-499a382c9a3b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2022
Manufacturers
FDA
MWI
DUNS: 019926120
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Atropine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13985-606
Application NumberNDA206289
Product Classification
M
Marketing Category
C73594
G
Generic Name
Atropine Sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 23, 2015
FDA Product Classification
INGREDIENTS (9)
Atropine SulfateActive
Quantity: 10 mg in 1 mL
Code: 03J5ZE7KA5
Classification: ACTIB
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT
Sodium Phosphate, DibasicInactive
Code: GR686LBA74
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Hypromellose 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
Sodium Phosphate, MonobasicInactive
Code: 3980JIH2SW
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT