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FDA Drug information

Roflumilast

Read time: 1 mins
Marketing start date: 18 Jun 2024

Summary of product characteristics


Effective Time

20230927

Version

3

Spl Product Data Elements

Roflumilast Roflumilast ROFLUMILAST ROFLUMILAST CELLULOSE, MICROCRYSTALLINE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLOXAMER 407 SILICON DIOXIDE STARCH, CORN off-white T5 Roflumilast Roflumilast ROFLUMILAST ROFLUMILAST CELLULOSE, MICROCRYSTALLINE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLOXAMER 407 SILICON DIOXIDE STARCH, CORN off-white T6

Application Number

ANDA208303

Brand Name

Roflumilast

Generic Name

Roflumilast

Product Ndc

70771-1673

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1674-3 Roflumilast Tablets, 500 mcg 30 tablets Rx only NDC 70771-1673-8 Roflumilast Tablets, 250 mcg Blister pack of 28 tablets Rx only 500 mcg label 250 mcg blister label

Spl Medguide

SPL MEDGUIDE

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