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FDA Drug information

Desvenlafaxine

Read time: 1 mins
Marketing start date: 27 Apr 2024

Summary of product characteristics


Effective Time

20230921

Version

7

Spl Product Data Elements

Desvenlafaxine Desvenlafaxine DESVENLAFAXINE DESVENLAFAXINE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE XANTHAN GUM WHITE TO OFF-WHITE SQUARE 469 Desvenlafaxine Desvenlafaxine DESVENLAFAXINE DESVENLAFAXINE CELLULOSE, MICROCRYSTALLINE FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE XANTHAN GUM ORANGE SQUARE 741 Desvenlafaxine Desvenlafaxine DESVENLAFAXINE DESVENLAFAXINE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSE 2208 (100 MPA.S) HYPROMELLOSE 2208 (15000 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 102 POLYETHYLENE GLYCOL 4000 POLYETHYLENE GLYCOL 6000 SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE XANTHAN GUM Light Yellow to Yellow Square 1257

Application Number

ANDA204020

Brand Name

Desvenlafaxine

Generic Name

Desvenlafaxine

Product Ndc

70771-1661

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Desvenlafaxine Extended-release Tablets, 25 mg NDC 70771-1661-3 30 tablets Rx only NDC 68382-469-67 in bottle of 14 tablets in unit-of-use package Desvenlafaxine Extended-release Tablets, 50 mg 14 tablets R x only Zydus NDC 68382-741-67 in bottle of 14 tablets in unit-of-use package Desvenlafaxine Extended-release Tablets, 100 mg 14 tablets R x only Zydus 25 mg Desvenlafaxine tablets Desvenlafaxine tablets

Spl Medguide

SPL MEDGUIDE

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