NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Approved
Approval ID
64e4cb91-f5bd-4a2f-b92d-0a1341f40d35
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 9, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-347
Application NumberANDA062423
Product Classification
M
Marketing Category
C73584
G
Generic Name
NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 9, 2010
FDA Product Classification
INGREDIENTS (11)
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 mL
Code: 057Y626693
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
THIMEROSALInactive
Code: 2225PI3MOV
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIB
HYDROCORTISONEActive
Quantity: 10 mg in 1 mL
Code: WI4X0X7BPJ
Classification: ACTIB