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FDA Drug information

Tramadol Hydrochloride and Acetaminophen

Read time: 1 mins
Marketing start date: 28 Apr 2024

Summary of product characteristics


Effective Time

20230927

Version

7

Spl Product Data Elements

Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen ACETAMINOPHEN ACETAMINOPHEN TRAMADOL HYDROCHLORIDE TRAMADOL HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 6000 STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE WHITE CAPSULE 334

Application Number

ANDA090460

Brand Name

Tramadol Hydrochloride and Acetaminophen

Generic Name

Tramadol Hydrochloride and Acetaminophen

Product Ndc

65841-758

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Tramadol Hydrochloride and Acetaminophen Tablets USP, 37.5 mg/325 mg NDC 65841-758-01 100 Tablets Rx only labels

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