Glenmark Pharmaceuticals Inc., USA

FDA Drug Class II Ongoing

Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Prades

October 23, 2023 Glenmark Pharmaceuticals Inc., USA 16,944 bottles units

FDA Drug Class III Terminated

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceutic

October 23, 2023 Glenmark Pharmaceuticals Inc., USA 8,448 30-count bottles, 168 1000-count bottles units

FDA Drug Class III Terminated

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufacture

October 20, 2023 Glenmark Pharmaceuticals Inc., USA 480 100-count bottles units

FDA Drug Class II Ongoing

Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30

October 20, 2023 Glenmark Pharmaceuticals Inc., USA 5,856 bottles units

FDA Drug Class III Ongoing

Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactu

August 14, 2023 Glenmark Pharmaceuticals Inc., USA 1,200 bottles units

FDA Drug Class III Ongoing

Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured f

July 11, 2022 Glenmark Pharmaceuticals Inc., USA 654,756 tubes units

FDA Drug Class III Ongoing

Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-405-60.

June 29, 2022 Glenmark Pharmaceuticals Inc., USA 168936 bottles units

FDA Drug Class II Terminated

Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya

June 29, 2022 Glenmark Pharmaceuticals Inc., USA 72288 units units

FDA Drug Class II Terminated

Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madh

June 29, 2022 Glenmark Pharmaceuticals Inc., USA

FDA Drug Class II Terminated

Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, Ind

June 29, 2022 Glenmark Pharmaceuticals Inc., USA 36 bottles units

FDA Drug Class III Terminated

Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himach

June 16, 2022 Glenmark Pharmaceuticals Inc., USA 98, 307 packs units

FDA Drug Class II Completed

Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC

April 25, 2022 Glenmark Pharmaceuticals Inc., USA a) 7,044 bottles; b) 1,014 bottles units

FDA Drug Class II Completed

Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahw

April 25, 2022 Glenmark Pharmaceuticals Inc., USA 11,136 bottles units

FDA Drug Class II Completed

Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mah

April 25, 2022 Glenmark Pharmaceuticals Inc., USA 12,003 bottles units

FDA Drug Class II Terminated

Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68

August 27, 2021 Glenmark Pharmaceuticals Inc., USA a) 216,454 bottles; b) 2166 bottles units

FDA Drug Class II Terminated

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32

August 27, 2021 Glenmark Pharmaceuticals Inc., USA 28658 cartons units

FDA Drug Class II Terminated

Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ

August 27, 2021 Glenmark Pharmaceuticals Inc., USA 15936 bottles units

FDA Drug Class II Terminated

Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceutical

August 27, 2021 Glenmark Pharmaceuticals Inc., USA 1800 bottles units

FDA Drug Class II Terminated

Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceutical

August 27, 2021 Glenmark Pharmaceuticals Inc., USA 4752 bottles units

FDA Drug Class II Terminated

Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 0743

August 27, 2021 Glenmark Pharmaceuticals Inc., USA a) 31248 bottles; b) 300 bottles units

FDA Drug Class II Terminated

Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals

August 27, 2021 Glenmark Pharmaceuticals Inc., USA a) 5362 inhalers; b) 5593 inhalers units

FDA Drug Class II Terminated

Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceutic

August 27, 2021 Glenmark Pharmaceuticals Inc., USA 9552 bottles units

FDA Drug Class II Ongoing

Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwa

December 17, 2019 Glenmark Pharmaceuticals Inc., USA 1,712,632 bottles units

FDA Drug Class II Ongoing

Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwa

December 17, 2019 Glenmark Pharmaceuticals Inc., USA 1,309,536 bottles units

FDA Drug Class II Ongoing

Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah

December 17, 2019 Glenmark Pharmaceuticals Inc., USA 98,988 bottles units

FDA Drug Class II Ongoing

Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah,

December 17, 2019 Glenmark Pharmaceuticals Inc., USA 217,956 bottles units

FDA Drug Class II Ongoing

Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah,

December 17, 2019 Glenmark Pharmaceuticals Inc., USA 500,960 bottles units

FDA Drug Class II Ongoing

Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah,

December 17, 2019 Glenmark Pharmaceuticals Inc., USA 208,668 bottles units

FDA Drug Class III Terminated

Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25,

November 15, 2019 Glenmark Pharmaceuticals Inc., USA a) 480 packs; b) 240 packs units

FDA Drug Class III Terminated

Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurang

November 15, 2019 Glenmark Pharmaceuticals Inc., USA a) 34521 bottles; b) 16930 bottles units

FDA Drug Class II Terminated

Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators)

October 22, 2019 Glenmark Pharmaceuticals Inc., USA 216,840 cartons units

FDA Drug Class III Terminated

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Village: Kishanpura, Baddi Nalagarth Road, District: Solan, Hima

August 7, 2019 Glenmark Pharmaceuticals Inc., USA 31,224 tubes units

FDA Drug Class II Terminated

Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanp

July 23, 2019 Glenmark Pharmaceuticals Inc., USA N/A units

FDA Drug Class II Terminated

Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Ma

June 3, 2019 Glenmark Pharmaceuticals Inc., USA 31,656 boxes units

FDA Drug Class II Terminated

Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, Ind

March 25, 2019 Glenmark Pharmaceuticals Inc., USA 2076 500-count Bottles units

FDA Drug Class II Terminated

Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa Ind

December 26, 2018 Glenmark Pharmaceuticals Inc., USA 96,240 applicators units

FDA Drug Class III Terminated

Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40

November 27, 2018 Glenmark Pharmaceuticals Inc., USA 5,016 blister packs units

FDA Drug Class III Terminated

Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Ma

March 19, 2018 Glenmark Pharmaceuticals Inc., USA 109,080 Bottles units

FDA Drug Class II Terminated

Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 6846201925

November 20, 2017 Glenmark Pharmaceuticals Inc., USA 5136 tubes units