Cromolyn Sodium
Cromolyn Sodium Ophthalmic Solution USP, 4% Sterile
Approved
Approval ID
34ef00e8-0c01-4225-9a40-822ab245752a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cromolyn Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71205-230
Application NumberANDA075282
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cromolyn Sodium
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 1, 2019
FDA Product Classification
INGREDIENTS (6)
CROMOLYN SODIUMActive
Quantity: 40 mg in 1 mL
Code: Q2WXR1I0PK
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT