Levobunolol Hydrochloride
Levobunolol Hydrochloride Ophthalmic Solution
Approved
Approval ID
bf29d224-0ab2-41fa-92d9-3f7520c525b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 12, 2012
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.
Levobunolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3363
Application NumberANDA074326
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levobunolol Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 12, 2012
FDA Product Classification
INGREDIENTS (11)
LEVOBUNOLOL HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: O90S49LDHH
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT