Diclofenac
Diclofenac Sodium Ophthalmic Solution 0_1
Approved
Approval ID
5372866a-dab3-45c8-8c2a-755ca36c1791
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 28, 2022
Manufacturers
FDA
Altaire Pharmaceuticals Inc.
DUNS: 786790378
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diclofenac Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59390-149
Application NumberANDA203383
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 31, 2022
FDA Product Classification
INGREDIENTS (7)
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 1 mg in 1 mL
Code: QTG126297Q
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT