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FDA Drug information

Etodolac

Read time: 1 mins
Marketing start date: 30 Apr 2024
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Summary of product characteristics


Effective Time

20230926

Version

7

Spl Product Data Elements

Etodolac Etodolac ETODOLAC ETODOLAC D&C YELLOW NO. 10 ETHYLCELLULOSE (100 MPA.S) FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE TRIACETIN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS ORANGE OVAL 271 Etodolac Etodolac ETODOLAC ETODOLAC ETHYLCELLULOSE (100 MPA.S) FD&C BLUE NO. 2 FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE TRIACETIN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS GRAY OVAL 272 Etodolac Etodolac ETODOLAC ETODOLAC ETHYLCELLULOSE (100 MPA.S) FD&C BLUE NO. 2 FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE TRIACETIN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS BLUE OVAL 273

Application Number

ANDA091134

Brand Name

Etodolac

Generic Name

Etodolac

Product Ndc

65841-777

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-777-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 400 mg R x only 60 tablets NDC 65841-778-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 500 mg R x only 60 tablets NDC 65841-779-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 600 mg R x only 60 tablets Etodolac Extended-release Tablets USP, 400 mg Etodolac Extended-release Tablets USP, 500 mg Etodolac Extended-release Tablets USP, 600 mg

Spl Medguide

SPL MEDGUIDE

Drug section

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