GlaxoSmithKline, LLC.

FDA Drug Class III Terminated

Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: Vi

May 17, 2024 GlaxoSmithKline, LLC. 463 Cartons units

FDA Drug Class III Terminated

ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869

December 12, 2023 GlaxoSmithKline, LLC. 67,508 inhalers units

FDA Drug Class III Terminated

Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.

May 13, 2022 GlaxoSmithKline, LLC. 328 bottles units

FDA Drug Class II Ongoing

Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.

May 16, 2017 GlaxoSmithKline, LLC. 562,883 units

FDA Drug Class II Ongoing

Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20

March 22, 2017 GlaxoSmithKline, LLC. 593,088 inhalers units

FDA Drug Class II Terminated

Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-22,

July 18, 2016 GlaxoSmithKline, LLC. 28,131 tubes units

FDA Drug Class II Terminated

Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11.

July 18, 2016 GlaxoSmithKline, LLC. 153,119 tubes units

FDA Drug Class II Terminated

Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-25,

July 18, 2016 GlaxoSmithKline, LLC. 7,480 tubes units

FDA Drug Class II Terminated

Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,

July 18, 2016 GlaxoSmithKline, LLC. 18,000 tubes units

FDA Drug Class II Terminated

Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709,

December 3, 2015 GlaxoSmithKline, LLC. 128,704 Inhalers units

FDA Drug Class II Terminated

Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. N

August 13, 2015 GlaxoSmithKline, LLC. 88,489 tubes units

FDA Drug Class II Terminated

Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 00

August 13, 2015 GlaxoSmithKline, LLC. 19,520 tubes units

FDA Drug Class II Terminated

Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSm

August 13, 2015 GlaxoSmithKline, LLC. 28,480 tubes of 15g, 12,234 tubes of 30g units

FDA Drug Class II Terminated

Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Bo

August 13, 2015 GlaxoSmithKline, LLC. 166,070 of 15g tube, 112,720 of 30 g tube units

FDA Drug Class II Terminated

Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Res

November 6, 2013 GlaxoSmithKline, LLC. 9,743 cartridges units

FDA Drug Class II Terminated

Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for subcutaneous injection only, 1 imitrex STATdose Pen, 1

November 6, 2013 GlaxoSmithKline, LLC. 10,469 Systems units

FDA Drug Class III Terminated

TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135-0181-02

July 18, 2013 GlaxoSmithKline, LLC. 300,480 bottles units

FDA Drug Class III Terminated

Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.

October 24, 2012 GlaxoSmithKline, LLC. 18,676 Aerosol Units units

FDA Drug Class III Terminated

Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research

October 24, 2012 GlaxoSmithKline, LLC. 310,964 Aerosol Units units

FDA Drug Class II Terminated

Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06

October 8, 2012 GlaxoSmithKline, LLC. 1,319 vials units