Unichem Pharmaceuticals Usa Inc

FDA Drug Class III Ongoing

Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by

January 21, 2026 Unichem Pharmaceuticals Usa Inc 60,000 tablets units

FDA Drug Class II Ongoing

Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India

January 21, 2026 Unichem Pharmaceuticals Usa Inc N/A units

FDA Drug Class I Ongoing

Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem

August 27, 2025 Unichem Pharmaceuticals Usa Inc 230 90-count bottles units

FDA Drug Class III Terminated

Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM P

September 19, 2022 Unichem Pharmaceuticals Usa Inc 18,960 bottles of 100 units

FDA Drug Class III Terminated

Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA

October 25, 2021 Unichem Pharmaceuticals Usa Inc 1284 bottles units

FDA Drug Class III Terminated

Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem P

May 26, 2020 Unichem Pharmaceuticals Usa Inc 190,992 bottles units

FDA Drug Class III Terminated

Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pilerne Bardez, Goa 403 511 India. Manufactured for: Unichem Phar

January 29, 2020 Unichem Pharmaceuticals Usa Inc 19161600 units units

FDA Drug Class II Terminated

Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Phar

December 19, 2017 Unichem Pharmaceuticals Usa Inc 96,876 Bottles of 30s units

FDA Drug Class II Terminated

Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTIC

October 2, 2017 Unichem Pharmaceuticals Usa Inc 96,876 bottles units

FDA Drug Class III Terminated

Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Phar

August 19, 2016 Unichem Pharmaceuticals Usa Inc 368 bottles units

FDA Drug Class II Terminated

Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTIC

July 30, 2015 Unichem Pharmaceuticals Usa Inc 4776 bottles units