MIOSTAT
MIOSTAT™
Approved
Approval ID
f28d7a56-e079-4a8b-ad81-9a97c780de67
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 10, 2023
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.
carbachol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0065-0023
Application NumberNDA016968
Product Classification
M
Marketing Category
C73594
G
Generic Name
carbachol
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 30, 2022
FDA Product Classification
INGREDIENTS (10)
CARBACHOLActive
Quantity: 0.1 mg in 1 mL
Code: 8Y164V895Y
Classification: ACTIB
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT