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GENTAMICIN SULFATE

GENTAMICIN SULFATE o phthalmic s olution, USP 0.3% s terile

Approved
Approval ID

0bc9fa00-1755-4989-a222-a038e970371f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 30, 2018

Manufacturers
FDA

Pacific Pharma, Inc.

DUNS: 877645267

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

gentamicin sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60758-188
Application NumberANDA062452
Product Classification
M
Marketing Category
C73584
G
Generic Name
gentamicin sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 16, 2023
FDA Product Classification

INGREDIENTS (9)

GENTAMICIN SULFATEActive
Quantity: 3 mg in 1 mL
Code: 8X7386QRLV
Classification: ACTIM
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 7/30/2018

HOW SUPPLIED

Gentamicin sulfate ophthalmic solution, USP 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with beige high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle – NDC 60758-188-05

Storage**:**

Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above).

Revised**:******10/201****7

Distributed for: Allergan USA, Inc.
Madison, NJ 07940

©2017 Allergan. All rights reserved.
All trademarks are the property of their respective owners.
Made in the U.S.A.

v1.0USPI188

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GENTAMICIN SULFATE - FDA Drug Approval Details