Roflumilast
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
1 mins
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