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FDA Drug information

Naproxen

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

Summary of product characteristics


Effective Time

20230927

Version

5

Spl Product Data Elements

Naproxen Naproxen NAPROXEN NAPROXEN CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW MAGNESIUM STEARATE POVIDONE ZE10 Naproxen Naproxen NAPROXEN NAPROXEN CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW MAGNESIUM STEARATE POVIDONE yellow ZE9 Naproxen Naproxen NAPROXEN NAPROXEN CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW MAGNESIUM STEARATE POVIDONE ZE8

Application Number

ANDA078620

Brand Name

Naproxen

Generic Name

Naproxen

Product Ndc

65841-676

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-676-01 Naproxen tablets, 250 mg 100 Tablets Rx only NDC 65841-677-01 Naproxen tablets, 375 mg 100 Tablets Rx only NDC 65841-678-01 Naproxen tablets, 500 mg 100 Tablets Rx only Naproxen tablets Naproxen tablets Naproxen tablets

Spl Medguide

Manufactured by: Cadila Healthcare Ltd. India

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Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.