Diclofenac Sodium
Diclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)
Approved
Approval ID
6bec35d6-500d-4570-b2ff-ce7b4fc801df
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6283
Application NumberANDA078792
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 31, 2011
FDA Product Classification
INGREDIENTS (7)
EDETATE DISODIUMInactive
Quantity: 1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 1 mg in 1 mL
Code: QTG126297Q
Classification: ACTIB
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: X045WJ989B
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT