NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, USP
Approved
Approval ID
e6f8d2f6-adff-4ae1-982c-45562f0a8e28
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2022
Manufacturers
FDA
Bausch & Lomb Incorporated
DUNS: 196603781
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 gramicidin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24208-790
Application NumberANDA064047
Product Classification
M
Marketing Category
C73584
G
Generic Name
neomycin sulfate, polymyxin b sulfate and gramicidin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 2, 2022
FDA Product Classification
INGREDIENTS (11)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NEOMYCIN SULFATEActive
Quantity: 1.75 mg in 1 mL
Code: 057Y626693
Classification: ACTIM
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIM
GRAMICIDINActive
Quantity: 0.025 mg in 1 mL
Code: 5IE62321P4
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
THIMEROSALInactive
Quantity: 0.01 mg in 1 mL
Code: 2225PI3MOV
Classification: IACT