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  • Galantamine GALANTAMINE HYDROBROMIDE 8 mg/1 Zydus Lifesciences Limited
FDA Drug information

Galantamine

Read time: 1 mins
Marketing start date: 23 Dec 2024

Summary of product characteristics


Effective Time

20221013

Version

7

Spl Product Data Elements

Galantamine Galantamine GALANTAMINE HYDROBROMIDE GALANTAMINE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE PROPYLENE GLYCOL SILICON DIOXIDE TITANIUM DIOXIDE FERRIC OXIDE RED CROSPOVIDONE (15 MPA.S AT 5%) LIGHT PINK ROUND 77;Z Galantamine Galantamine GALANTAMINE HYDROBROMIDE GALANTAMINE CROSPOVIDONE (15 MPA.S AT 5%) FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE PROPYLENE GLYCOL SILICON DIOXIDE TITANIUM DIOXIDE OFF-WHITE ROUND 78;Z Galantamine Galantamine GALANTAMINE HYDROBROMIDE GALANTAMINE CROSPOVIDONE (15 MPA.S AT 5%) FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE PROPYLENE GLYCOL SILICON DIOXIDE TITANIUM DIOXIDE HYPROMELLOSES OFF-WHITE ROUND 79;Z

Application Number

ANDA078898

Brand Name

Galantamine

Generic Name

Galantamine

Product Ndc

65841-756

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-755-14 in bottle of 60 tablets Galantamine Tablets USP, 4 mg R x only 60 tablets NDC 65841-756-14 in bottle of 60 tablets Galantamine Tablets USP, 8 mg R x only 60 tablets NDC 65841-757-14 in bottle of 60 tablets Galantamine Tablets USP, 12 mg R x only 60 tablets galantamine tablets USP, 4mg galantamine Tablets USP, 8mg galantamine Tablets USP, 12mg

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