DICLOFENAC SODIUM liquid

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

Διαθέσιμο από:

Zydus Lifesciences Limited

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Diclofenac sodium topical solution is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product. [see Warnings and Precautions (5.7, 5.9)]. - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8)]. - In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)]. Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation. Risk Summary Use of NSAIDs, including diclofenac sodium topical solution, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs,

Περίληψη προϊόντος:

Diclofenac sodium topical solution, 1.5% w/w is supplied as a clear, colorless to faintly pink-orange solution containing 16.05 mg of diclofenac sodium, USP per mL of solution, in a white opaque high density polyethylene bottle with a white round continuous threaded polyethylene screw cap with dropper spout. NDC Number & Size 150 mL bottle                                                    NDC 70771-1415-9 Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 10/2023
Document Id: be77ee21-4c1b-48e6-a256-8efb852ff892
34391-3
Set id: 3eede6d4-a3e1-4dd4-bb18-a721320f7d10
Version: 5
Effective Time: 20231003
Zydus Lifesciences Limited

Αρχείο Π.Χ.Π.

DICLOFENAC SODIUM- DICLOFENAC SODIUM LIQUID
ZYDUS LIFESCIENCES LIMITED
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DICLOFENAC SODIUM TOPICAL SOLUTION
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1415-9
Diclofenac Sodium Topical Solution, 1.5% w/w
Rx only
Quantity 5 Fl. OZ.
(150 mL)
DICLOFENAC SODIUM
diclofenac sodium liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1415
ROUTE OF ADMINISTRATION
TOPICAL
Zydus Lifesciences Limited
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC -
UNII:144O8QL0L1)
DICLOFENAC SODIUM
16.05 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALCOHOL (UNII: 3K9958V90M)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1415-9
1 in 1 CARTON
08/08/2018
1
150 mL in 1 BOTTLE, DROPPER; Type 0: Not a
Combination Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA206411
08/08/2018
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (650650802)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
650650802
ANALYSIS(70771-1415) , MANUFACTURE(70771-1415)
Revised: 10/2023