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FDA Drug information

Venlafaxine Hydrochloride

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20230519

Version

1

Spl Product Data Elements

Venlafaxine Hydrochloride Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE VENLAFAXINE ETHYLCELLULOSE (7 MPA.S) FERROSOFERRIC OXIDE GELATIN HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (5 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 8000 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE WATER grey opaque colored cap white opaque colored body ZA;35;37;5;mg Venlafaxine Hydrochloride Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE VENLAFAXINE ETHYLCELLULOSE (7 MPA.S) FERRIC OXIDE RED FERROSOFERRIC OXIDE GELATIN HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (5 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 8000 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE WATER peach opaque colored cap white opaque colored body ZA;36;75;mg Venlafaxine Hydrochloride Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE VENLAFAXINE ETHYLCELLULOSE (7 MPA.S) FERRIC OXIDE RED FERROSOFERRIC OXIDE GELATIN HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (5 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 8000 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE WATER dark orange opaque colored cap white opaque colored body ZA;37;150;mg

Application Number

ANDA090174

Brand Name

Venlafaxine Hydrochloride

Generic Name

Venlafaxine Hydrochloride

Product Ndc

70771-1838

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1836-9 Venlafaxine Hydrochloride Extended-release Capsules USP, 37.5 mg 90 Capsules Rx only NDC 70771-1837-9 Venlafaxine Hydrochloride Extended-release Capsules USP, 75 mg 90 Capsules Rx only NDC 70771-1838-9 Venlafaxine Hydrochloride Extended-release Capsules USP, 150 mg 90 Capsules Rx only 37.5 mg label 75 mg label 150 mg label

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