tofacitinib
Summary of product characteristics
Effective Time
20230927
Version
3
Spl Product Data Elements
tofacitinib tofacitinib TOFACITINIB CITRATE TOFACITINIB D&C RED NO. 27 ALUMINUM LAKE ETHYLCELLULOSE (7 MPA.S) FD&C BLUE NO. 2--ALUMINUM LAKE FERRIC OXIDE RED FERROSOFERRIC OXIDE HYPROMELLOSE 2208 (100 MPA.S) HYPROMELLOSE 2208 (4000 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 4000 PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE TITANIUM DIOXIDE light pink to pink 1353 tofacitinib tofacitinib TOFACITINIB CITRATE TOFACITINIB ETHYLCELLULOSE (7 MPA.S) FERROSOFERRIC OXIDE HYPROMELLOSE 2208 (100 MPA.S) HYPROMELLOSE 2208 (4000 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 4000 PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE TITANIUM DIOXIDE off-white 1727
Application Number
ANDA214264
Brand Name
tofacitinib
Generic Name
tofacitinib
Product Ndc
70771-1627
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Tofacitinib extended-release tablets, 11 mg NDC 70771-1627-3 30 Tablets Rx only Tofacitinib extended-release tablets, 22 mg NDC 70771-1628-3 30 Tablets Rx only 11 mg 22 mg
Spl Medguide
SPL MEDGUIDE
100 mins
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