Macleods Pharma Usa Inc

FDA Drug Class II Ongoing

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceut

May 7, 2024 Macleods Pharma Usa Inc 1,048 bottles units

FDA Drug Class III Terminated

Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, I

January 5, 2023 Macleods Pharma Usa Inc 10052 bottles units

FDA Drug Class II Terminated

Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himacha

June 16, 2022 Macleods Pharma Usa Inc 168690 Tablets units

FDA Drug Class II Terminated

Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 0

June 10, 2022 Macleods Pharma Usa Inc 84/1000 count bottles units

FDA Drug Class II Terminated

Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma US

April 15, 2022 Macleods Pharma Usa Inc 3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tablets units

FDA Drug Class II Terminated

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx

April 15, 2022 Macleods Pharma Usa Inc N/A units

FDA Drug Class II Terminated

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx O

April 15, 2022 Macleods Pharma Usa Inc N/A units

FDA Drug Class II Terminated

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx

April 15, 2022 Macleods Pharma Usa Inc N/A units

FDA Drug Class II Terminated

Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma U

April 15, 2022 Macleods Pharma Usa Inc 3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets units

FDA Drug Class II Terminated

Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

April 15, 2022 Macleods Pharma Usa Inc 12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets units

FDA Drug Class III Terminated

Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, IN

March 10, 2022 Macleods Pharma Usa Inc 4872 bottles units

FDA Drug Class II Terminated

Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, In

February 16, 2022 Macleods Pharma Usa Inc 3672 bottles units

FDA Drug Class II Terminated

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd,

February 15, 2022 Macleods Pharma Usa Inc 3,672 bottles units

FDA Drug Class III Terminated

Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by:

October 18, 2021 Macleods Pharma Usa Inc 643,800 Blister Packs /888,336 Tablets units

FDA Drug Class III Terminated

Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only,

October 18, 2021 Macleods Pharma Usa Inc 135,082 Blister Packs/2,431,476 tablets units

FDA Drug Class III Terminated

Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by:

October 18, 2021 Macleods Pharma Usa Inc 13,260 Blister Packs/238,680 tablets units

FDA Drug Class II Terminated

Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutical Ltd., Baddi, Himachal, Pradesh,

August 2, 2021 Macleods Pharma Usa Inc 444,000 tablets / 888 unit packs of 500 count units

FDA Drug Class III Terminated

Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), In

March 22, 2021 Macleods Pharma Usa Inc 8015 packs units

FDA Drug Class III Terminated

Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals

January 24, 2020 Macleods Pharma Usa Inc 4694 30x60-count bottles units

FDA Drug Class III Terminated

Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh,

January 20, 2020 Macleods Pharma Usa Inc 10680 units units

FDA Drug Class II Terminated

Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pr

September 23, 2019 Macleods Pharma Usa Inc 31,968 bottles units

FDA Drug Class III Terminated

Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal P

August 21, 2019 Macleods Pharma Usa Inc 1837 90-count bottles units

FDA Drug Class II Terminated

Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 count (NDC 33342-159-44) bottles, Manufactured : Macleods Pharma US

July 17, 2019 Macleods Pharma Usa Inc a) 5448 bottles b) 972 bottles c) 158 bottles units

FDA Drug Class II Terminated

Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDI

June 20, 2019 Macleods Pharma Usa Inc 47520 bottles (4,276,800 tablets) units

FDA Drug Class II Terminated

Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Lt

June 20, 2019 Macleods Pharma Usa Inc 145162 bottles (13,064,580 tablets) units

FDA Drug Class II Terminated

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd

June 20, 2019 Macleods Pharma Usa Inc 29106 bottles (2,619,540 tablets) units

FDA Drug Class II Terminated

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd.

June 20, 2019 Macleods Pharma Usa Inc 142626 bottles (12,836,340 tablets) units

FDA Drug Class II Terminated

Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, I

June 20, 2019 Macleods Pharma Usa Inc 4277 bottles (4,277,000 tablets) units

FDA Drug Class II Terminated

Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd.

February 25, 2019 Macleods Pharma Usa Inc 93227 bottles units

FDA Drug Class II Terminated

Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Badd

February 25, 2019 Macleods Pharma Usa Inc 134495 bottles units

FDA Drug Class II Terminated

Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd

February 25, 2019 Macleods Pharma Usa Inc 140,589 bottles units

FDA Drug Class II Terminated

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmace

February 21, 2019 Macleods Pharma Usa Inc 9695 bottles units

FDA Drug Class II Terminated

Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal

December 24, 2015 Macleods Pharma Usa Inc N/A units